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R F Soll

Publications and source records attributed to R F Soll.

At least 19 recordsLinked to original sources
PubMed2006

The clinical impact of high frequency ventilation: review of the Cochrane meta-analyses.

Experimental work in animal models suggests that ventilation strategies using high frequency oscillatory ventilation or high frequency jet ventilation hold great promise in the prevention of lung injury in preterm infants. However, clinical trials of either modality demonstrate little clinical benefit and there are possibilities of adverse effects, including increased risk of intraventricular hemorrhage and poor neurological development.

Bronchopulmonary Dysplasia↗
PubMed2004

Topical ointment for preventing infection in preterm infants.

BACKGROUND: Nosocomial sepsis is a frequent and serious complication of premature infants. The increased susceptibility of ELBW infants to infection has been attributed to less effective immune function compared to mature newborns and the invasive nature of necessary supportive care. Breakdown of the barrier function of the skin may be an additional risk factor for nosocomial sepsis. OBJECTIVES: To assess the effect of prophylactic application of topical ointment on nosocomial sepsis rates and other complications of prematurity in preterm infants. SEARCH STRATEGY: Searches were made of the Cochrane Central Registry of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2003), Ovid DC MEDLINE through June 2003, previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants, and journal hand searching in the English language. SELECTION CRITERIA: Randomized controlled trials which compared the effect of prophylactic application of topical ointment to routine (standard) skin care or as needed topical therapy in preterm infants are included in this review. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes including infection [including any bacterial infection, bacterial infection with a known pathogen, coagulase negative staphylococcal infection, fungal infection, and any nosocomial infection (bacterial or fungal)], patent ductus arteriosus, oxygen requirement at 28 days, chronic lung disease and mortality were excerpted from the reports of the clinical trials by the reviewers. Data analysis was done in accordance with the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: Four randomized controlled trials were identified. All four studies reported improved skin condition in infants treated with prophylactic topical ointment (results not reported here). All four studies reported on the incidence of any nosocomial infection, fungal infection and coagulase negative staphylococcal infection. Infants treated with prophylactic topical ointment are at increased risk of coagulase negative staphylococcal infection (typical relative risk 1.31, 95% CI 1.02, 1.70; typical risk difference 0.04, 95% CI 0.00, 0.08); and any nosocomial infection (typical relative risk 1.20, 95% CI 1.00, 1.43; typical risk difference 0.05, 95% CI 0.00, 0.09). A trend toward increased risk of any bacterial infection was found in infants treated with prophylactic topical ointment (typical relative risk 1.19, 95% CI 0.97, 1.46; typical risk difference 0.04, 95% CI -0.01, 0.08). There was no significant difference found in the risk of bacterial infection with a known pathogen, fungal infection, or other complications related to prematurity. REVIEWER'S CONCLUSIONS: Prophylactic application of topical ointment increases the risk of coagulase negative staphylococcal infection and any nosocomial infection. A trend toward increased risk of any bacterial infection was noted in infants prophylactically treated. Topical ointment should not be used routinely in preterm infants.

Cross Infection↗
PubMed2004

Early surfactant administration with brief ventilation vs selective surfactant and continued mechanical ventilation for preterm infants with or at risk for respiratory distress syndrome.

BACKGROUND: Both prophylactic and early surfactant replacement therapy, compared with later selective surfactant administration, reduce mortality and pulmonary complications in ventilated infants with respiratory distress syndrome (RDS). However, continued post-surfactant intubation and ventilation are risk factors for chronic lung disease. Whether prophylactic or early surfactant administration followed by prompt extubation, compared with later, selective use of surfactant followed by continued mechanical ventilation reduces the need for mechanical ventilation and the incidence of chronic lung disease is unknown. OBJECTIVES: To compare two treatment strategies in preterm infants with, or at risk for, RDS: early surfactant administration with brief mechanical ventilation (less than one hour) followed by extubation, vs later, selective surfactant administration, continued mechanical ventilation and extubation from low respiratory support. Two populations of infants receiving early surfactant were considered: spontaneously breathing infants with signs of RDS (surfactant administration during evolution of RDS prior to requiring intubation for respiratory failure) and infants at high risk for RDS (prophylactic surfactant administration within 15 minutes after birth). SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal trials, MEDLINE (1966-December 2003), CINAHL (1982-December 2003), EMBASE (1980-December 2003), Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2004), Pediatric Research (1990-2003), abstracts, expert informants and hand searching. No language restrictions were applied. SELECTION CRITERIA: Randomized or quasi-randomized controlled clinical trials comparing early surfactant administration with planned brief mechanical ventilation (less than one hour) followed by extubation, vs selective surfactant administration, continued mechanical ventilation and extubation from low respiratory support. DATA COLLECTION AND ANALYSIS: Data were sought regarding effects on incidence of mechanical ventilation (ventilation continued or initiated beyond one hour after surfactant administration), incidence of bronchopulmonary dysplasia (BPD), chronic lung disease (CLD), mortality, duration of mechanical ventilation, duration of hospitalization, time in oxygen, duration of respiratory support (including CPAP and nasal cannula), number of patients receiving surfactant, number of surfactant doses administered per patient, incidence of air leak syndromes (pulmonary interstitial emphysema, pneumothorax), patent ductus arteriosus requiring treatment, pulmonary hemorrhage, and other complications of prematurity. Treatment effect was expressed as relative risk (RR) and risk difference (RD) for categorical variables, and weighted mean difference (WMD) for continuous variables. MAIN RESULTS: Four randomized controlled clinical trials met selection criteria and were included in this review. In these studies of infants with signs of RDS, intubation and early surfactant therapy followed by extubation to nasal CPAP (NCPAP) compared with later selective surfactant administration was associated with a lower incidence of mechanical ventilation [typical RR 0.70, 95% CI 0.59, 0.84]. None of the trials reported a significant difference in the incidence of BPD or CLD; however, meta-analysis for this outcome cannot yet be performed because the primary data from three of the trials have not yet been published in full. A larger proportion of infants in the early surfactant group received surfactant than in the selective surfactant group [typical RR 1.59, 95% CI 1.35, 1.88]. The number of surfactant doses per patient was significantly greater among patients randomized to the early surfactant group [WMD 0.51 doses per patient, 95% CI 0.36, 0.65]. Trends towards a decreased incidence of air leak syndromes (two studies) and a higher incidence of patent ductus arteriosus requiring treatment (one study) were seen in the early surfactant group. There was no evidence of effect on time in oxygen or duration of mechanical ventilation. REVIEWERS' CONCLUSIONS: Early surfactant replacement therapy with extubation to NCPAP compared with later, selective surfactant replacement and continued mechanical ventilation with extubation from low ventilator support is associated with a reduced need for mechanical ventilation and increased utilization of exogenous surfactant therapy. There is insufficient evidence at present to reliably evaluate effect on BPD or CLD.

Humans↗
PubMed2003

Metalloporphyrins for treatment of unconjugated hyperbilirubinemia in neonates.

BACKGROUND: Metalloporphyrins are heme analogues that inhibit heme oxygenase, the rate-limiting enzyme in the catabolism of heme to bilirubin. By preventing the formation of bilirubin, they have the potential to reduce the level of unconjugated bilirubin in neonates and thereby reduce the risk of neonatal encephalopathy and long term neurodevelopmental impairment from bilirubin toxicity to the nervous system. OBJECTIVES: 1. To determine the efficacy of metalloporphyrins in reducing bilirubin levels, reducing the need for phototherapy or exchange transfusion and reducing the incidence of bilirubin encephalopathy in neonates with unconjugated hyperbilirubinemia when compared to placebo, phototherapy or exchange transfusion. 2. To determine the nature and frequency of side effects of metalloporphyrins when used to treat unconjugated hyperbilirubinemia in neonates. SEARCH STRATEGY: We searched Medline (1966 - January 2003) and the Cochrane Controlled Trials Register (CCTR) from the Cochrane Library (2003, issue 1). We hand-searched the articles cited in each publication obtained. We hand searched the abstracts of the Society for Pediatric Research (USA) (published in Pediatric Research) for the years 1985 - 2002. SELECTION CRITERIA: We included only randomized controlled studies, in which preterm or term neonates (age 28 days of life or less) with unconjugated hyperbilirubinemia due to any cause were randomly allocated to receive a metalloporphyrin in the treatment arm(s), and to receive a placebo or a conventional treatment (phototherapy or exchange transfusion) or no treatment for hyperbilirubinemia in the comparison arm(s). Any preparation of metalloporphyrin could be used, in any form, by any route, at any dose. DATA COLLECTION AND ANALYSIS: Two authors extracted data independently. Data were entered into Revman by one author and checked by a second author. Prespecified subgroup analyses were planned in term versus preterm infants, hemolytic versus non-hemolytic causes of jaundice and according to the type of metalloporphyrin used. MAIN RESULTS: Three small studies, enrolling a total of 170 infants, were eligible for inclusion in this review. None blinded intervention or outcome assessment. In all three studies some patients were excluded after randomization. Metalloporphyrin-treated infants appeared to have short-term benefits compared to controls, including a lower maximum plasma bilirubin level in one study, a lower frequency of severe hyperbilirubinemia in one study, a decreased need for phototherapy, fewer plasma bilirubin measurements and a shorter duration of hospitalization. None of the enrolled infants required an exchange transfusion in the two studies that described this outcome. None of the studies reported on neonatal kernicterus, death, long-term neurodevelopmental outcomes or iron deficiency anemia. Though a small number of metalloporphyrin-treated as well as control infants developed a photosensitivity rash, the trials were too small to rule out an increase in the risk of photosensitivity or other adverse effects from metalloporphyrin treatment. No subgroup analyses were possible due to the small number of included trials. REVIEWER'S CONCLUSIONS: Treatment of neonatal unconjugated hyperbilirubinemia with metalloporphyrins may reduce neonatal bilirubin levels and decrease the need for phototherapy and hospitalization. There is no evidence to support or refute the possibility that treatment with a metalloporphyrin decreases the risk of neonatal kernicterus or of long-term neurodevelopmental impairment due to bilirubin encephalopathy. There is no evidence to support or refute the possibility that cutaneous photosensitivity is increased with metalloporphyrin treatment. Routine treatment of neonatal unconjugated hyperbilirubinemia with a metalloporphyrin cannot be recommended at present.

Humans↗
PubMed2003

Exogenous surfactant therapy in newborn infants.

Exogenous surfactant therapy has an established role in the management of neonatal respiratory distress syndrome (RDS). This article summarises the current evidence on surfactant therapy. The use of surfactant for the treatment or prophylaxis of neonatal RDS results in a 30% to 65% relative reduction in the risk of pneumothorax and up to a 40% relative reduction in the risk of mortality. Adverse effects, of which pulmonary haemorrhage is of most concern, are infrequent and long-term follow-up studies of treated patients are reassuring. Natural surfactants have advantages over synthetic surfactants, including a lower frequency of pneumothorax and a lower mortality. Prophylactic administration of surfactant is preferred over 'rescue' administration, especially in infants of < 30 weeks' gestation, as it decreases the risk of pneumothorax, pulmonary interstitial emphysema and neonatal mortality. Prophylaxis can be administered after initial resuscitation and stabilisation. In preterm infants who do not receive prophylactic surfactant, the first dose of surfactant should be administered as early as possible--early selective treatment decreases the risk of pneumothorax, pulmonary interstitial emphysema, chronic lung disease and neonatal mortality. A regimen of using multiple doses of surfactant if required has advantages over a single dose regimen. Exogenous surfactant therapy has also been used in neonatal respiratory disorders other than RDS. In trials in severe meconium aspiration syndrome, surfactant therapy reduced the need for extracorporeal membrane oxygenation. Its role in other disorders requires testing. The development and testing of newer surfactants is in progress.

Humans↗
PubMed2002

Early surfactant administration with brief ventilation vs selective surfactant and continued mechanical ventilation for preterm infants with or at risk for RDS.

BACKGROUND: Both early and prophylactic surfactant replacement therapy compared with later selective surfactant administration reduces mortality and pulmonary complications in ventilated infants with respiratory distress syndrome (RDS). Continuous distending pressure (CDP) has also been shown to improve clinical outcomes in preterm infants with RDS. OBJECTIVES: To compare two treatment strategies in preterm infants with, or at risk for, RDS: early surfactant administration with brief mechanical ventilation (less than 1 hour) followed by extubation, vs later, selective surfactant administration, continued mechanical ventilation and extubation from low respiratory support. Two populations of infants receiving early surfactant were considered: spontaneously breathing infants with signs of RDS (surfactant administration during evolution of RDS prior to requiring intubation for respiratory failure) and infants at high risk for RDS (prophylactic surfactant administration within 15 minutes after birth). SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal trials, MEDLINE (1966-December 2001), CINAHL (1982-December 2001), EMBASE (1980-December 2001), Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2002), Pediatric Research (1990-2001), abstracts, expert informants and hand searching. No language restrictions were applied. SELECTION CRITERIA: Randomized or quasi-randomized controlled clinical trials comparing early surfactant administration with planned brief mechanical ventilation (less than one hour) followed by extubation, vs selective surfactant administration, continued mechanical ventilation and extubation from low respiratory support. DATA COLLECTION AND ANALYSIS: Data were sought regarding effects on incidence of mechanical ventilation (ventilation continued or initiated beyond one hour after surfactant administration), incidence of bronchopulmonary dysplasia (BPD, need for oxygen at 28 days of age), incidence of chronic lung disease (CLD, need for oxygen at 36 weeks' post-conceptional age), mortality (neonatal mortality < 28 days and mortality prior to hospital discharge), duration of mechanical ventilation, duration of hospitalization, time in oxygen, duration of respiratory support (including CPAP and nasal cannula), number of patients receiving surfactant, number of surfactant doses administered per patient, incidence of air leak syndromes (pulmonary interstitial emphysema, pneumothorax), incidence of pulmonary hemorrhage, and other complications of prematurity. Data analyses were performed in accordance with the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: Only one randomized controlled clinical trial met selection criteria and was included in this review (Verder 1994). In this study of infants with signs of RDS, intubation and early surfactant therapy followed by extubation to nasal CPAP (NCPAP) compared with later, selective surfactant administration was associated with a lower incidence of mechanical ventilation (ventilation continuing for one hour or more after surfactant administration in the early surfactant group or initiated for respiratory insufficiency or apnea in either group [RR 0.51, 95% CI 0.32, 0.76]). A larger proportion of infants in the early surfactant group received surfactant than in the selective surfactant group [RR 1.74, 95% CI 1.30, 2.33]. The number of surfactant doses per patient was significantly greater among patients randomized to the early surfactant group [MD 0.51, 95% CI 0.32, 0.70]. Trends towards a decreased incidence of mortality, and a higher rate of patent ductus arteriosus requiring treatment were seen in the early surfactant group. There was no evidence of effect on median time in oxygen, duration of mechanical ventilation, or incidence of BPD (oxygen at 28 days). REVIEWER'S CONCLUSIONS: Early surfactant replacement therapy with extubation to NCPAP compared with later, selective surfactant replacement and continued mechanical ventilation with extubation from low ventilator support is associated with a reduced need for mechanical ventilation and increased utilization of exogenous surfactant therapy. These conclusions are based on findings from one small randomized clinical trial. Additional randomized trials are needed and are underway.

Combined Modality Therapy↗
PubMed2001

Superoxide dismutase for preventing chronic lung disease in mechanically ventilated preterm infants.

BACKGROUND: Free oxygen radicals have been implicated in the pathogenesis of chronic lung disease in preterm infants. Superoxide dismutase is a naturally occurring enzyme which provides a defence against such oxidant injury. Exogenously administered superoxide dismutase has been tested in clinical trials to prevent chronic lung disease in preterm infants. OBJECTIVES: To determine if exogenously administered superoxide dismutase is efficacious in the prevention of chronic lung disease in preterm infants who are mechanically ventilated, and efficacious in decreasing the following outcomes: bronchopulmonary dysplasia, intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotizing enterocolitis, patent ductus arteriosus and mortality. To determine the frequency and nature of adverse effects of superoxide dismutase. SEARCH STRATEGY: We searched Medline (1966 - 2000) and the Cochrane Controlled Trials Register (CCTR) using the following keywords: [bronchopulmonary dysplasia OR chronic lung disease] AND superoxide dismutase, limited to human studies in newborn infants (infant, newborn). We hand searched the reference lists of articles located and the abstracts of the Society for Pediatric Research (USA) (published in Pediatric Research) from 1980 - 2000. SELECTION CRITERIA: Randomized controlled trials where subjects were preterm infants who had developed or were at risk of developing respiratory distress syndrome requiring assisted ventilation and who were randomly allocated to receive either superoxide dismutase (in any form, by any route) or placebo or no treatment. We included studies which reported any of the following outcomes: chronic lung disease, bronchopulmonary dysplasia, any intraventricular hemorrhage, intraventricular hemorrhage grades III/IV, patent ductus arteriosus, periventricular leukomalacia, retinopathy of prematurity, necrotizing enterocolitis, neonatal mortality, death prior to discharge and neurodevelopmental outcome. DATA COLLECTION AND ANALYSIS: We extracted and assessed separately all data for each study and entered final data into RevMan. We did not perform subgroup analyses (which were originally planned) because only two studies were eligible for inclusion. We assessed the methodological quality of the studies by assessing the risk for bias. We pooled the outcomes of infants who had developed bronchopulmonary dysplasia at 28 days with those who had died at 28 days to derive the combined outcome of bronchopulmonary dysplasia or death at 28 days. Similarly we pooled the outcomes of infants who had respiratory problems after discharge with those who had died prior to discharge to derive the combined outcome of respiratory problems after discharge or death. We used the standard method of the Cochrane Neonatal Review Group for statistical analysis, using a fixed effect model. MAIN RESULTS: Two randomized controlled trials were included for analysis. No differences were found in either study or in the pooled data in death prior to discharge, oxygen dependency at 36 weeks corrected age, oxygen dependency at 28 days of life or in other outcomes. In one study (Rosenfeld 1984), survivors who had been treated with superoxide dismutase had a shorter duration of continuous positive airway pressure (4.9 vs 9.7 days), a lower frequency of respiratory problems after discharge (relative risk 0.33, 95% confidence limits 0.11, 0.96) and a lower frequency of chest radiograph abnormalities (relative risk 0.30, 95% confidence limits 0.11, 0.87) compared to survivors who received placebo. A third study was available only in abstract form and will be evaluated for inclusion after publication. REVIEWER'S CONCLUSIONS: Based on currently available published trials, there is insufficient evidence to draw firm conclusions about the efficacy of superoxide dismutase in preventing chronic lung disease of prematurity. Data from a small number of treated infants suggest that it is well tolerated and has no serious adverse effects.

Bronchopulmonary Dysplasia↗
PubMed2001

Current surfactant use in premature infants.

Exogenous surfactant therapy has been a significant advance in the management of preterm infants with RDS. It has become established as a standard part of the management of such infants. Both natural and synthetic surfactants lead to clinical improvement and decreased mortality, with natural surfactants having additional advantages over currently available synthetic surfactants. The use of prophylactic surfactant administered after initial stabilization at birth to infants at risk for RDS has benefits compared with rescue surfactant given to treat infants with established RDS. In infants who do not receive prophylaxis, earlier treatment (before 2 hours) has benefits over later treatment. The use of multiple doses of surfactant is a superior strategy to the use of a single dose, whereas the use of a higher threshold for retreatment seems to be as effective as a low threshold. Adverse effects of surfactant therapy are infrequent and usually not serious. Long-term follow-up of infants treated with surfactant in the neonatal period is reassuring. In the future we are likely to see the development of new types of surfactants. Further research is required to determine the optimal use of surfactant in conjunction with other respiratory interventions.

Drug Combinations↗
PubMed2001

Collaborative quality improvement for neonatal intensive care. NIC/Q Project Investigators of the Vermont Oxford Network.

OBJECTIVE: To make measurable improvements in the quality and cost of neonatal intensive care using a multidisciplinary collaborative quality improvement model. DESIGN: Interventional study. Patient demographic and clinical information for infants with birth weight 501 to 1500 g was collected using the Vermont Oxford Network Database for January 1, 1994 to December 31, 1997. SETTING: Ten self-selected neonatal intensive care units (NICUs) received the intervention. They formed 2 subgroups (6 NICUs working on infection, 4 NICUs working on chronic lung disease). Sixty-six other NICUs served as a contemporaneous comparison group. PATIENTS: Infants with birth weight 501 to 1500 g born at or admitted within 28 days of birth between 1994 and 1997 to the 6 study NICUs in the infection group (n = 3063) and the 66 comparison NICUs (n = 21 509); infants with birth weight 501 to 1000 g at the 4 study NICUs in the chronic lung disease group (n = 738). INTERVENTIONS: NICUs formed multidisciplinary teams that worked together under the direction of a trained facilitator over a 3-year period beginning in January 1995. They received instruction in quality improvement, reviewed performance data, identified common improvement goals, and implemented "potentially better practices" developed through analysis of the processes of care, literature review, and site visits. MAIN OUTCOME MEASURES: The rates of infection after the third day of life with coagulase-negative staphylococcal or other bacterial pathogens for infants with birth weight 501 to 1500 g, and the rates of oxygen supplementation or death at 36 weeks' adjusted gestational age for infants with birth weight 501 to 1000 g. RESULTS: Between 1994 and 1996, the rate of infection with coagulase-negative staphylococcus decreased from 22.0% to 16.6% at the 6 project NICUs in the infection group; the rate of supplemental oxygen at 36 weeks' adjusted gestational age decreased from 43.5% to 31.5% at the 4 NICUs in the chronic lung disease group. There was heterogeneity in the effects among the NICUs in both project groups. The changes observed at the project NICUs for these outcomes were significantly larger than those observed at the 66 comparison NICUs over the 4-year period from 1994 to 1997. CONCLUSION: We conclude that multidisciplinary collaborative quality improvement has the potential to improve the outcomes of neonatal intensive care.

Chronic Disease↗
PubMed2001

Economic implications of neonatal intensive care unit collaborative quality improvement.

OBJECTIVE: To make measurable improvements in the quality and cost of neonatal intensive care using a multidisciplinary collaborative quality improvement model. DESIGN: Interventional study. Data on treatment costs were collected for infants with birth weight 501 to 1500 g for the period of January 1, 1994 to December 31, 1997. Data on resources expended by hospitals to conduct this project were collected in a survey for the period January 1, 1995 to December 31, 1996. SETTING: Ten self-selected neonatal intensive care units (NICUs) received the intervention. They formed 2 subgroups (6 NICUs working on infection, 4 NICUs working on chronic lung disease). Nine other NICUs served as a contemporaneous comparison group. PATIENTS: Infants with birth weight 501 to 1500 g born at or admitted within 28 days of birth between 1994 and 1997 to the 6 study NICUs in the infection group (N = 2993) and the 9 comparison NICUs (N = 2203); infants with birth weight 501 to 1000 g at the 4 study NICUs in the chronic lung disease group (N = 663) and the 9 comparison NICUs (N = 1007). INTERVENTIONS: NICUs formed multidisciplinary teams which worked together to undertake a collaborative quality improvement effort between January 1995 and December 1996. They received instruction in quality improvement, reviewed performance data, identified common improvement goals, and implemented "potentially better practices" developed through analysis of the processes of care, literature review, and site visits. MAIN OUTCOME MEASURES: Treatment cost per infant is the primary economic outcome measure. In addition, the resources spent by hospitals in undertaking the collaborative quality improvement effort were determined. RESULTS: Between 1994 and 1996, the median treatment cost per infant with birth weight 501 to 1500 g at the 6 project NICUs in the infection group decreased from $57 606 to $46 674 (a statistical decline); at the 4 chronic lung disease hospitals, for infants with birth weights 501 to 1000 g, it decreased from $85 959 to $77 250. Treatment costs at hospitals in the control group rose over the same period. There was heterogeneity in the effects among the NICUs in both project groups. Cost savings were maintained in the year following the intervention. On average, hospitals spent $68 206 in resources to undertake the collaborative quality improvement effort between 1995 and 1996. Two thirds of these costs were incurred in the first year, with the remaining third in the second year. The average savings per hospital in patient care costs for very low birth weight infants in the infection group was $2.3 million in the post-intervention year (1996). There was considerable heterogeneity in the cost savings across hospitals associated with participation in the collaborative quality improvement project. CONCLUSION: Cost savings may be achieved as a result of collaborative quality improvement efforts and when they occur, they appear to be sustainable, at least in the short run. In high-cost patient populations, such as infants with very low birth weights, cost savings can quickly offset institutional expenditures for quality improvement efforts.

Chronic Disease↗
PubMed2000

Multiple versus single dose natural surfactant extract for severe neonatal respiratory distress syndrome.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: To compare the effect of multiple doses of natural surfactant extract to single doses of natural surfactant extract in premature infants with established respiratory distress syndrome. SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: pulmonary surfactant; limits: age groups, newborn infant; publication type, clinical trials), previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants, and journal hand searching in the English language. SELECTION CRITERIA: Randomized controlled trials comparing a policy of multiple doses of natural surfactant extract to a policy of single doses of natural surfactant extract in premature infants with respiratory distress syndrome were considered for this review. DATA COLLECTION AND ANALYSIS: Data on clinical outcomes including pneumothorax, patent ductus arteriosus, necrotizing enterocolitis, intraventricular hemorrhage (all intraventricular hemorrhage and severe intraventricular hemorrhage), chronic lung disease, retinopathy of prematurity, and mortality were excerpted by the primary reviewer (R. Soll). Data were analyzed according to the standards of the Neonatal Cochrane Review Group. MAIN RESULTS: Two randomized controlled trials of multiple vs. single dose natural surfactant extract in infants with established respiratory distress syndrome were identified. Meta-analysis of these trials suggests a reduction in the risk of pneumothorax (typical relative risk 0.51, 95% CI 0.30, 0.88; typical risk difference-0.09, 95% CI -0.15, -0. 02) and a trend towards a reduction in mortality (typical relative risk 0.63, 95% CI 0.39, 1.02; typical risk difference -0.07, 95% CI -0.14, 00.00). No complications associated with multiple dose treatment are reported in the identified trials. REVIEWER'S CONCLUSIONS: In infants with established respiratory distress, a policy of multiple doses of natural surfactant extract results in greater improvements regarding oxygenation and ventilatory requirements, a decreased risk of pneumothorax and a trend toward improved survival. The ability to give multiple doses of surfactant to infants with ongoing respiratory insufficiency leads to improved clinical outcome and appears to be the most effective treatment policy.

Drug Administration Schedule↗
PubMed2000

Natural surfactant extract versus synthetic surfactant for neonatal respiratory distress syndrome.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: To compare the effect of synthetic surfactant to natural surfactant in premature infants with established respiratory distress syndrome. SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: pulmonary surfactant; limits: age groups, newborn infant; publication type, clinical trial), previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants, and journal hand searching in the English language. SELECTION CRITERIA: Randomized controlled trials comparing administration of synthetic surfactants to administration of natural surfactant extracts in premature infants with respiratory distress syndrome were considered for this review. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes including pneumothorax, patent ductus arteriosus, necrotizing enterocolitis, intraventricular hemorrhage (all intraventricular hemorrhage and severe intraventricular hemorrhage), chronic lung disease, retinopathy of prematurity, and mortality were excerpted by the primary reviewer (R. Soll). Data analysis was conducted according to the standards of the Neonatal Cochrane Review Group. MAIN RESULTS: The meta-analysis supports a significant reduction in the risk of pneumothorax (typical relative risk 0.68, 95% CI 0.56, 0.83; typical risk difference -0.04 95% CI -0.06, -0.02). No disadvantages to natural surfactant extract treatment are noted regarding other outcomes. A trend towards reduced mortality is noted in association with natural surfactant extract treatment. REVIEWER'S CONCLUSIONS: Both natural surfactant extracts and synthetic surfactant extracts are effective in the treatment of established respiratory distress syndrome. Comparative trials demonstrate greater early improvement in the requirement for ventilatory support and fewer pneumothoraces associated with natural surfactant extract treatment. On clinical grounds, natural surfactant extracts would seem to be the more desirable choice.

Biological Products↗
PubMed2000

Prophylactic versus selective use of surfactant for preventing morbidity and mortality in preterm infants.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: To compare the effect of prophylactic surfactant administration to surfactant treatment of established respiratory distress syndrome in premature infants. SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: pulmonary surfactant; limits: age groups, newborn infants), previous reviews including cross-references, abstracts, conference and symposia proceedings, expert informants, and journal handsearching in the English language. SELECTION CRITERIA: Randomized controlled trials which compared the effects of prophylactic surfactant administration to surfactant treatment of established respiratory distress syndrome in premature infants were included in the analysis. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes including the incidence of pneumothorax, pulmonary interstitial emphysema, patent ductus arteriosus, necrotizing enterocolitis, intraventricular hemorrhage (any grade and severe intraventricular hemorrhage), bronchopulmonary dysplasia, mortality, bronchopulmonary dysplasia or death, and retinopathy of prematurity were excerpted from the reports of the clinical trials by the reviewers. Data analysis was done in accordance with the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: The majority of included studies noted an initial improvement in the respiratory status and a decrease in the incidence of respiratory distress syndrome in infants who received prophylactic surfactant. The meta-analysis supports a decrease in the incidence of pneumothorax, a decrease in the incidence of pulmonary interstitial emphysema, a decrease in the incidence of mortality and a decrease in the incidence of bronchopulmonary dysplasia or death associated with prophylactic administration of surfactant. No significant untoward effects of prophylactic surfactant administration are noted. REVIEWER'S CONCLUSIONS: Prophylactic surfactant administration to infants judged to be at risk of developing respiratory distress syndrome (intubated infants less than 30-32 weeks gestation) has been demonstrated to improve clinical outcome. Infants who receive prophylactic surfactant have a decreased incidence of pneumothorax, a decreased incidence of pulmonary interstitial emphysema and a decreased incidence of mortality. However, it remains unclear exactly which criteria should be used to judge "at risk" infants who would require prophylactic surfactant administration.

Humans↗
PubMed2000

Prophylactic natural surfactant extract for preventing morbidity and mortality in preterm infants.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: To assess the effect of prophylactic intratracheal administration of natural surfactant extract in preterm newborns at risk for developing respiratory distress syndrome (RDS). SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: pulmonary surfactant; limits: age groups; newborn infants), previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants and journal hand searching in the English language. SELECTION CRITERIA: Randomized controlled trials which compared the effect of prophylactic natural surfactant administration (surfactant obtained from human or bovine sources, either modified with additional phospholipids or not) administered to high risk preterm newborns at or shortly after birth in order to prevent respiratory distress syndrome, other complications of prematurity, and mortality. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes including incidence of pneumothorax, pulmonary interstitial emphysema, patent ductus arteriosus, necrotizing enterocolitis, intraventricular hemorrhage (any grade and severe intraventricular hemorrhage), bronchopulmonary dysplasia, mortality, bronchopulmonary dysplasia or death, and retinopathy of prematurity were excerpted from the reports of the clinical trials by the reviewer. Data analysis was done in accordance with the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: All of the included studies note an initial improvement in respiratory status and a decrease in the risk of respiratory distress syndrome in infants who receive prophylactic natural surfactant extract. The meta-analysis supports a decrease in the risk of pneumothorax (typical relative risk 0.35, 95% CI 0.26, 0.49; typical risk difference -0.15, 95% CI -0.20, -0.11), a decrease in the risk pulmonary interstitial emphysema (typical relative risk 0.46, 95% CI 0.35, 0.60; typical risk difference -0.19, 95% CI -0.25, -0.13), a decrease in the risk of neonatal mortality (typical relative risk 0. 60, 95% CI 0.44, 0.83; typical risk difference -0.07, 95% CI -0.12, -0.03), and a decrease in the risk of bronchopulmonary dysplasia or death (typical relative risk 0.84, 95% CI 0.75, 0.93; typical risk difference -0.10, 95% CI -0.16, -0.04. No differences are reported in the risk of intraventricular hemorrhage, patent ductus arteriosus, necrotizing enterocolitis or retinopathy of prematurity. Few data are available on long-term followup of treated infants. REVIEWER'S CONCLUSIONS: Prophylactic intratracheal administration of natural surfactant extract to infants judged to be at risk of developing respiratory distress syndrome (intubated infants <30 weeks gestation) has been demonstrated to improve clinical outcome. Infants who receive prophylactic natural surfactant extract have a decreased risk of pneumothorax, a decreased risk of pulmonary interstitial emphysema, a decreased risk of mortality, and a decreased risk of bronchopulmonary dysplasia or death.

Humans↗
PubMed2000

Prophylactic synthetic surfactant for preventing morbidity and mortality in preterm infants.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: To assess the effect of prophylactic administration of synthetic surfactant in preterm newborns at risk for developing respiratory distress syndrome (RDS). SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: pulmonary surfactant; limits: age groups, newborn infants; publication type, clinical trial), previous reviews including cross-references, abstracts, conference and symposia proceedings, expert informants, and journal hand searching in the English language. SELECTION CRITERIA: Randomized, controlled trials which compared the effect of prophylactic synthetic surfactant administered to high risk preterm newborns at or shortly after birth in order to prevent respiratory distress syndrome and other complications of prematurity. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes including the incidence of pneumothorax, pulmonary interstitial emphysema, patent ductus arteriosus, necrotizing enterocolitis, intraventricular hemorrhage (any grade and severe intraventricular hemorrhage), bronchopulmonary dysplasia, mortality, bronchopulmonary dysplasia or death, retinopathy of prematurity (any retinopathy, and retinopathy stages 3-4) mortality to one year of age, and cerebral palsy was excerpted from the report of the clinical trials by the reviewer. Data were analyzed according to the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: Studies of prophylactic administration of synthetic surfactant note a variable improvement in the respiratory status and a decrease in respiratory distress syndrome in infants who receive prophylactic synthetic surfactant. The meta-analysis supports a decrease in the risk of pneumothorax (typical relative risk 0.67, 95% CI 0.50, 0.90; typical risk difference -0.05, 95% CI -0.09, -0. 02), a decrease in the risk of pulmonary interstitial emphysema (typical relative risk 0.68, 95% CI 0.50, 0.93; typical risk difference -0.06, 95% CI -0.11, -0.01), and a decrease in risk of neonatal mortality (typical relative risk 0.70, 95% CI 0.58, 0.85; typical risk difference -0.07, 95% CI -0.11, -0.03). No differences were seen in the risk of intraventricular hemorrhage, necrotizing enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity and cerebral palsy. The meta-analysis supports an increase in the risk of patent ductus arteriosus associated with prophylactic synthetic surfactant administration (typical relative risk 1.11, 95% CI 1.00, 1.22; typical risk difference 0.05, 95% CI 0. 00,0.10), and an increase in the risk of pulmonary hemorrhage (typical relative risk 3.28, 95% CI 1.50, 7.16; typical risk difference 0.03, 95% CI 0.01, 0.05). REVIEWER'S CONCLUSIONS: Prophylactic intratracheal administration of synthetic surfactant to infants judged to be at risk of developing respiratory distress syndrome has been demonstrated to improve clinical outcome. Infants who receive prophylactic synthetic surfactant have a decreased risk of pneumothorax, a decreased risk of pulmonary interstitial emphysema, and a decreased risk of neonatal mortality. Infants who receive prophylactic synthetic surfactant have an increased risk of developing patent ductus arteriosus and pulmonary hemorrhage.

Humans↗
PubMed2000

Digoxin for preventing or treating neonatal respiratory distress syndrome.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: To assess the effect of digoxin on clinical outcome in infants at risk of, or with, respiratory distress syndrome (RDS). SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: digoxin; limits: age groups, newborn infants; publication type, clinical trial), previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants, and journal handsearching in the English language. SELECTION CRITERIA: Randomized controlled trials of digoxin in either the prevention or treatment of respiratory distress syndrome are included in this overview. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes were excerpted from the trial reports by the reviewer. Data were analyzed according to the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: Two randomized controlled trials have studied the effects of digoxin in the prevention and treatment of respiratory distress syndrome. No improvement in respiratory status or mortality was noted. Meta-analysis of the effect of digoxin given to infants at risk of or with RDS on mortality does not suggest any benefit of digoxin treatment (typical relative risk 1.27 95% CI 0.78, 2.07; typical risk difference 0.06, 95% CI -0.06, 0.17). REVIEWER'S CONCLUSIONS: Although hemodynamic disturbances play a role in the overall pathogenesis of respiratory distress syndrome, the specific contribution of early congestive heart failure (unrelated to hemodynamically significant patent ductus arteriosus) does not appear to be a significant factor in RDS. Treatment with digoxin has no proven value in infants solely affected with respiratory distress syndrome.

Cardiotonic Agents↗
PubMed2000

Synthetic surfactant for respiratory distress syndrome in preterm infants.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: To assess the effect of intratracheal administration of synthetic surfactant in premature newborns with established respiratory distress syndrome (RDS). SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: pulmonary surfactants; limits: age groups, newborn infant; publication types, clinical trial), previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants, and journal handsearching in the English language. SELECTION CRITERIA: Randomized controlled trials which compared the effect of synthetic surfactant treatment to routine management in the treatment of preterm infants with respiratory distress syndrome. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcome including the incidence of pneumothorax, pulmonary interstitial emphysema, pulmonary hemorrhage, patent ductus arteriosus, necrotizing enterocolitis, apnea of prematurity, intraventricular hemorrhage (any grade, and severe intraventricular hemorrhage), bronchopulmonary dysplasia, neonatal mortality, bronchopulmonary dysplasia or death, retinopathy of prematurity (any retinopathy, and retinopathy greater than Stage 3), mortality at hospital discharge, mortality to one year of age, and cerebral palsy (any, and moderate/severe cerebral palsy) was excerpted from the report of the clinical trials by the reviewer. Data were analyzed according to the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: Six randomized controlled trials of synthetic surfactant treatment of established respiratory distress syndrome were identified. Five of the studies used Exosurf Neonatal (a synthetic surfactant composed of dipalmitoylphosphatidylcholine, hexadecanol and tyloxapol); one small study utilized a mixture of dipalmitoylphosphatidylcholine (DPPC) and phosphatidylglycerol (PG). Treatment with intratracheal Exosurf Neonatal in premature infants with established respiratory distress syndrome improves pulmonary gas exchange and decreases the requirement for ventilatory support. In individual trials, the use of Exosurf Neonatal resulted in a statistically significant reduction in pneumothorax, patent ductus arteriosus, bronchopulmonary dysplasia (BPD), BPD or death at 28 days, and mortality. Similar results are seen when these large trials of Exosurf Neonatal are analyzed in conjunction with the smaller trial of dry powdered DPPC and phosphatidylglycerol (PG). The meta-analysis supports a decrease in the risk of pneumothorax (typical relative risk 0.64, 95% CI 0.55, 0.76, typical risk difference -0.09, 95% CI -0.12,-0.06), a decrease in the risk of pulmonary interstitial emphysema (typical relative risk 0.62, 95% CI 0.54, 0.71, typical risk difference -0.12, 95% CI -0.16, -0.09), a decrease in the risk of patent ductus arteriosus (typical relative risk 0.90, 95% CI 0.84, 0.97; typical risk difference -0.06 95% CI -0.10, -0.02), a decrease in the risk of intraventricular hemorrhage (typical relative risk 0.88, 95% CI 0.77, 0.99; typical risk difference -0.04, 95% CI -0.08, -0.00), a decrease in the risk of bronchopulmonary dysplasia (typical relative risk 0.75, 95% CI 0.61, 0.92; typical risk difference -0.04, 95% CI -0.06, -0.01), a decrease in the risk of neonatal mortality (typical relative risk 0. 73, 95% CI 0.61, 0.88; typical risk difference -0.05, 95% CI -0.07, -0.02), a decrease in the risk of bronchopulmonary dysplasia or death at 28 days (typical relative risk 0.73, 95% CI 0.65, 0.83; typical risk difference -0.06, 95% CI -0.11, -0.05), a decrease in the risk of mortality prior to hospital discharge (typical relative risk 0.79, 95% CI 0.68, 0.92; typical risk difference -0.05, 95% CI -0.07, -0.02) and a decrease in the risk of mortality during the first year of life (typical relative risk 0.80, 95% CI 0.69, 0.94; typical risk difference -0.04, 95% CI -0.07, -0.01). (ABS

Humans↗
PubMed2000

Emollient ointment for preventing infection in preterm infants.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: To assess the effect of prophylactic application of emollient ointment in preterm infants. SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: ointment; limits: age groups, newborn infant; publication types, clinical trial), previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants, and journal handsearching in the English language. SELECTION CRITERIA: Randomized controlled trials which compared the effect of prophylactic application of emollient ointment to routine care or as needed topical therapy in preterm infants are included in this review. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes including transepidermal water loss, skin condition, fluid intake, suspect infection and proven nosocomial infection were excerpted from the reports of the clinical trials by the reviewers. Data analysis was done in accordance with the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: Two randomized trials which compared prophylactic application of ointment to routine skin care or as needed topical ointment therapy were identified. Lane (1993) noted improved skin condition in infants receiving topical application of emollient ointment. In the study of Nopper and coworkers (1996), prophylactic application of ointment significantly decreased transepidermal water loss during the first six hours after initial application. Skin condition was noted to be improved during the first 1-2 weeks. Surveillance cultures demonstrated less bacterial colonization during the two week study. A significant decrease in suspect and proven infection was noted. Fewer infants were evaluated for sepsis among the group who received prophylactic application of ointment (relative risk 0. 50, 95% CI 0.27, 0.93; risk difference -0.30, 95% CI -0.54, -0.06). Both studies reported on the incidence of proven nosocomial infection. A trend towards a decrease in the risk of proven nosocomial infection was noted in infants who received prophylactic application of emollient ointment (typical relative risk 0.29, 95% CI 0.07, 1.16, typical risk difference -0.13, 95% CI -0.25, -0.01). REVIEWER'S CONCLUSIONS: In two small studies, prophylactic application of emollient ointment decreased transepidermal water loss, decreased the severity of dermatitis, and decreased the risk of suspect sepsis and proven sepsis. Further clinical studies are warranted to validate these results.

Cross Infection↗