Search PubMed⌕ Search

Biomedical subjects

R F Soll

Publications and source records attributed to R F Soll.

At least 37 records · Page 2Linked to original sources
PubMed2000

Diuretics for respiratory distress syndrome in preterm infants.

BACKGROUND: Lung edema may complicate respiratory distress syndrome (RDS) in preterm infants. OBJECTIVES: The aim of this review was to assess the risks and benefits of diuretic administration in preterm infants with RDS. SEARCH STRATEGY: We used the standard search method of the Cochrane Neonatal Review Group. We searched Medline, Embase and the Cochrane Controlled Trials Register from the Cochrane Library, using the following keywords: and . In addition, we searched the abstract books of the American Thoracic Society and Pediatric Research Societies. SELECTION CRITERIA: We only included trials in which preterm infants with RDS and less than 5 days of age were randomly allocated to diuretic administration. Of those trials, we only included studies in which at least one of the following outcomes measures was evaluated: mortality, patent ductus arteriosus, hypovolemic shock, intraventricular hemorrhage, renal failure, duration of oxygen supplementation, duration of mechanical ventilation, need for oxygen supplementation at 28 days of life, oxygen supplementation at 36 weeks of postconceptional age (gestational age + postnatal age), length of stay, number of rehospitalizations during the first year of life, and neurodevelopmental outcome. DATA COLLECTION AND ANALYSIS: We used the standard method for the Cochrane Collaboration which is described in the Cochrane Collaboration Handbook. Two investigators extracted, assessed and coded separately all data for each study. Any disagreement was resolved by discussion. MAIN RESULTS: Six studies met inclusion criteria. Studies available for this systematic review were all done before the current era of prenatal steroids, surfactant, indomethacin and fluid restriction. Furosemide administration had no long-term benefits. Furosemide-induced transient improvement in pulmonary function did not outweigh an increased risk for patent ductus arteriosus and for hemodynamic instability. REVIEWER'S CONCLUSIONS: There are no current data to support routine diuretic administration in preterm infants with RDS. Elective administration of furosemide or any diuretic to any patient with RDS should be carefully weighed against the risk of precipitating hypovolemia. In addition, elective administration of furosemide should be weighed against the risk of developing a symptomatic patent ductus arteriosus.

Diuretics↗
PubMed2000

Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: To compare the effects of early vs. delayed selective surfactant therapy for newborns intubated for respiratory distress within the first two hours of life. Planned subgroup analyses include separate comparisons for studies utilizing natural surfactant extract and synthetic surfactant. SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: pulmonary surfactant; text word: early; limits: age, newborn: publication type, clinical trial), PubMed, abstracts, conference and symposia proceedings, expert informants, and journal hand searching in the English language. SELECTION CRITERIA: Only randomized controlled clinical trials comparing early selective surfactant administration (surfactant administration via the endotracheal tube in infants intubated for respiratory distress, not specifically for surfactant dosage) within the first 2 hours of life versus delayed selective surfactant administration to infants with established respiratory distress syndrome were considered for review. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes including the incidence of pneumothorax, patent ductus arteriosus, pulmonary interstitial emphysema, pulmonary hemorrhage, necrotizing enterocolitis, retinopathy of prematurity, intraventricular hemorrhage (any and severe IVH), bronchopulmonary dysplasia, chronic lung disease, neonatal mortality, mortality prior to hospital discharge, bronchopulmonary dysplasia or death, and chronic lung disease or death were excerpted from the reports of the clinical trials by the reviewers. Data regarding the average number of surfactant doses per infant were also analyzed. Further analysis of data with regard to surfactant type was performed. Data analysis was performed in accordance with the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: Four randomized controlled trials met selection criteria. Two of the trials utilized synthetic surfactant (Exosurf Neonatal) and two utilized a natural surfactant extract. The meta-analyses demonstrated significant reductions in risk of pneumothorax (Typical RR 0.70, 95%CI 0.59, 0.82; Typical RD -0.05, 95%CI -0.08, -0.03), and pulmonary interstitial emphysema (Typical RR 0.63, 95%CI 0.43, 0.93; Typical RD -0.06, 95%CI -0.10, -0.01) in infants randomized to early selective surfactant administration. Infants randomized to early selective surfactant administration also demonstrated a decreased risk of neonatal mortality (Typical RR 0.87, 95%CI 0.77, 0.99; Typical RD -0.03, 95%CI -0.06, -0.00), chronic lung disease (Typical RR 0.70, 95%CI 0. 55, 0.88; Typical RD -0.03, 95%CI -0.05, -0.01), and chronic lung disease or death at 36 weeks (Typical RR 0.84, 95%CI 0.75, 0.93; Typical RD -0.06, 95%CI -0.09, -0.03). A trend toward risk reduction for bronchopulmonary dysplasia or death at 28 days was also evident (Typical RR 0.94, 95%CI 0.88, 1.00; Typical RD -0.04, 95%CI -0.07, -0.00). No differences in other complications of RDS or prematurity were noted. REVIEWER'S CONCLUSIONS: Early selective surfactant administration given to infants with RDS requiring assisted ventilation leads to a decreased risk of acute pulmonary injury (decreased risk of pneumothorax and pulmonary interstitial emphysema) and a decreased risk of neonatal mortality and chronic lung disease compared to delaying treatment of such infants until they develop established RDS.

Humans↗
PubMed2000

Surfactant for meconium aspiration syndrome in full term infants.

OBJECTIVES: To evaluate the effect of surfactant administration in the treatment of term infants with meconium aspiration syndrome. SEARCH STRATEGY: Searches were made using Medline (1985 to January 2000) (MeSH terms: pulmonary surfactant and meconium aspiration; limits: age groups, newborns; publication type, clinical trials), previous reviews including cross-references, abstracts, conference and symposia proceedings, expert informants, and journal hand searching in the English language. Authors were directly contacted to provide additional data. SELECTION CRITERIA: Randomized controlled trials which evaluated the effect of surfactant administration in term infants with meconium aspiration syndrome are included in the analysis. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes including duration of assisted ventilation, duration of supplemental oxygen, pneumothorax, intraventricular hemorrhage (any grade and severe IVH), chronic lung disease, treatment with extracorporeal membrane oxygenation (ECMO), and mortality were excerpted from the reports of the clinical trails by the reviewers. Data analysis was done in accordance with the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: Two randomized controlled trials met inclusion criteria. Findlay (1996) reports a decrease in the risk of pneumothorax (relative risk 0.09, 95% CI 0.01, 1.54, risk difference -0.25, 95% CI -0.45, -0.05). Both Findlay (1996) and Lotze (1998) report a decrease in the number of infants receiving extracorporeal membrane oxygenation. The meta-analysis supports a significant reduction in the risk of requiring extracorporeal membrane oxygenation (typical relative risk 0.64, 95% CI 0.46, 0.91 typical risk difference -0.17, 95% CI -0.30, -0.04). No difference was noted in overall mortality (typical relative risk 1.86 95% CI 0.35, 9.89, typical risk difference 0.02 95% CI -0.03, 0.07). REVIEWER'S CONCLUSIONS: In infants with meconium aspiration syndrome, surfactant administration may reduce the severity of respiratory illness and decrease the number of infants with progressive respiratory failure requiring support with ECMO. The relative efficacy of surfactant therapy compared to, or in conjunction with, other approaches to treatment including inhaled nitric oxide, liquid ventilation, and high frequency ventilation remains to be tested.

Humans↗
PubMed1999

The principles and practice of evidence-based neonatology.

Significant strides toward improving the outcome of newborn infants have been observed during the modern era of neonatal-perinatal medicine. One of the challenges that neonatologists and pediatricians face is deciding when to change current practices. New literature is abundant, but it must be critically reviewed and evaluated before changes in practice are made. The evidence-based medicine process can be used to help in changing practices or adopting new practices. It is based on five steps: 1) forming answerable questions; 2) searching for the best evidence; 3) critically appraising the evidence; 4) applying the evidence in practice; and 5) evaluating one's performance. This article reviews the five steps of the evidence-based medicine process. The various levels of evidence, including randomized, controlled trials and systematic reviews, are defined and discussed. An example of a critically appraised topic, a practical tool that can be used as an aid in addressing the first three questions of the evidence-based medicine process, is included. Once the evidence has been evaluated, the decision of whether or not to implement a change in individual practice or in institutional guidelines must be made. These decisions are difficult and require a variety of individual and societal factors to be taken into account. Examples of evidence-based medicine in neonatal and perinatal medicine include the use of antenatal corticosteroids for promotion of lung maturity, the use of surfactant replacement therapy for the treatment and prevention of respiratory distress syndrome, and prophylactic indomethacin for the prevention of intraventricular hemorrhage. Review of these examples provides insight into the strengths and weaknesses of evidence-based medicine.

Adrenal Cortex Hormones↗
PubMed1996

Appropriate surfactant usage in 1996.

Surfactant therapy has been proven effective in the prevention and treatment of respiratory distress syndrome. Over 6,000 infants have been studied in randomized controlled trials. These studies have demonstrated that both prophylactic administration of surfactant and administration of surfactant to premature infants with established respiratory distress syndrome will decrease the risk of pneumothorax and decrease the risk of mortality. Currently, over 50% of very low birth weight infants in North America receive some sort of surfactant preparation. However, many questions remain regarding optimal usage of surfactant preparations. Recent randomized controlled trials have evaluated issues regarding surfactant dosage, treatment strategy, method of administration, and surfactant preparation. Initial doses in the range of 100-200 mg/kg with repeat doses to selected infants who relapse appears to be the best approach to therapy. Prophylactic surfactant therapy leads to a small but statistically significant reduction in the risk of pneumothorax and mortality. The clinical relevance of these advantages and the cost effectiveness of this care remains under debate. A variety of methods of administration have been used in randomized controlled trials. Trials which compare these methods of administration demonstrate the adequacy of currently tested bolus administration. However, other methods of administration, such as slow infusion of surfactant leads to uneven distribution of surfactant and poor response. Both synthetic surfactants and natural surfactant extracts have been proven effective in the care of these infants. However, randomized controlled trials which directly compare these two preparations demonstrate a small advantage to the use of natural surfactant extracts. Natural surfactant extracts improve initial ventilatory status and decrease the risk of pneumothorax. Surfactant replacement therapy has proven to be effective in the treatment of very low birth weight premature infants. Current clinical trials support the early institution of treatment either prophylactically or as soon as possible in intubated babies with signs of respiratory distress syndrome. Repeat treatment may be important in optimizing outcome due to surfactant inactivation. Currently available natural surfactant extracts improve early clinical outcome and decrease pneumothorax compared to the available synthetic preparations.

Animals↗
PubMed1995

The pharmacokinetics and lipoprotein fraction distribution of intramuscular vs. oral vitamin K1 supplementation in women of childbearing age: effects on hemostasis.

Prenatal maternal vitamin K1 supplementation to improve the hemostatic status of the fetus may depend upon the route of administration and subsequent presentation at the placental barrier. We investigated intramuscular (IM) vs oral (PO) vitamin K1 supplementation in eight healthy, nonpregnant women of childbearing age. Pharmacokinetics were studied in each subject after a 5 mg IM dose and after a 5 mg oral dose of vitamin K1 approximately one month later. Plasma collected at the peak vitamin K level for each treatment was separated into very low density lipoproteins (VLDL), low density lipoprotein (LDL), high density lipoprotein (HDL) and lipoprotein-free fractions by density gradient ultracentrifugation. Vitamin K1 was measured in the plasma and lipoprotein fractions using HPLC. The concentration of vitamin K1 in plasma reached a peak 2 h after an IM dose and remained high throughout the 30 h course of the study. In contrast, the oral dose of vitamin K1 peaked at 4 h and rapidly decreased to near baseline by 18 to 30 h. The distribution of vitamin K1 in the lipid fractions was different for IM compared to PO. The percentage of vitamin K1 in the VLDL fraction at the peak for an oral dose was significantly higher than for an IM dose (80.8% +/- 3.5 vs 10.8% +/- 6.5, p < 0.0001). After the oral absorption stage, the subjects took 5 mg of vitamin K1 orally, once a day, for 12 days. No significant differences were observed for the following coagulation proteins and hemostatic markers measured immediately before and after long-term oral vitamin K supplementation: factor II, factor VII, protein C, and thrombin-antithrombin III complex. In conclusion, physiological processing of supplemented vitamin K1 differs in the IM vs PO routes of administration and 12 days of oral vitamin K1 does not alter the concentration of selected vitamin K-dependent coagulation proteins or thrombin-antithrombin complex generation.

Administration, Oral↗
PubMed1994

Artificial versus natural surfactant--can we base clinical practice on a firm scientific footing?

Now that surfactant is in widespread use, clinical trials are beginning to address the critical question of whether the choice of surfactant really matters in terms of major morbidity and mortality. The trials reported so far focus on the effects of artificial and natural surfactant on acute gas exchange and duration of oxygen or ventilation therapy. Although the number of infants recruited to comparative trials of different surfactants is increasing, we are still a long way from being able reliably to answer the question 'Which type of surfactant should we use and under what circumstances?' In understanding the uncertainty in this field it is pertinent to consider the interrelationships between three levels of research for any new therapy in clinical science. At the first level animal studies or case reports suggest potential clinical benefits. At the second, more focused physiological studies and trials address questions of mechanism. At the third, definitive randomised trials compare major adverse clinical outcomes in human patients. Only studies conducted at this third level can finally establish clinical practice on a firm scientific footing. In this review, a preliminary meta-analysis of 801 patients recruited in three trials of artificial (Exosurf) versus natural (Survanta) surfactant shows no clear advantage for either surfactant but does not rule out moderate differences in major adverse outcomes. To establish reliably whether such differences exist will require large multicentre clinical trials.(ABSTRACT TRUNCATED AT 250 WORDS)

Biological Products↗
PubMed1993

Vitamin K1 metabolism and the production of des-carboxy prothrombin and protein C in the term and premature neonate.

This study investigated the incidences of undercarboxylated (protein induced by vitamin K absence: PIVKA) prothrombin and protein C in 496 neonates across a wide range of gestational ages. These findings are related to vitamin K1 levels (an indicator of cofactor availability) and vitamin K1 epoxide levels (a measure of the efficiency of the hepatic vitamin K cycle). PIVKA protein C was present in at least trace amounts in 27% of infants; whereas, PIVKA prothrombin was present in 7% of infants. PIVKA prothrombin and protein C were present at high plasma concentrations in 2% to 3% of term and preterm neonates and both PIVKA protein C and prothrombin increased with gestational age. Despite elevated plasma concentrations of PIVKA protein C and diminished levels of normally carboxylated protein C, clinical thrombosis was not observed. The mean (+/- SD) vitamin K1 level in the study population was 0.009 +/- 0.02 nmol/L (adult reference interval: 0.3 to 2.6 nmol/L) with no clear relationship between vitamin K1 levels and production of PIVKA protein C or prothrombin. By comparison with adults, the epoxide form of the vitamin comprised an abnormally high proportion of total vitamin K1; this suggests possible inefficiencies in hepatic reductase cycling.

Biomarkers↗
PubMed1993

A multicenter randomized trial comparing two surfactants for the treatment of neonatal respiratory distress syndrome. National Institute of Child Health and Human Development Neonatal Research Network.

OBJECTIVE: To compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome. DESIGN: Multicenter randomized trial. SETTING: Eleven tertiary care university neonatal intensive care units participating in the National Institute of Child Health and Human Development Neonatal Research Network. PATIENTS: Newborn infants (n = 617) weighing 501 to 1500 gm with respiratory distress syndrome who were receiving assisted ventilation with 30% oxygen or more within 6 hours of birth were enrolled between January 1991 and January 1992. INTERVENTIONS: Infants were randomly assigned to receive up to four intratracheal doses of either Exosurf Neonatal (n = 309) or Survanta (n = 308). MAIN OUTCOME MEASURES: The occurrence of death or bronchopulmonary dysplasia 28 days after birth and the average fraction of inspired oxygen (FIO2) and mean airway pressure (MAP) during the first 72 hours after treatment. RESULTS: Death or bronchopulmonary dysplasia occurred in 67% of the infants in the Exosurf group and 62% of those in the Survanta group (adjusted relative risk, 1.07; 95% confidence interval, 0.96 to 1.20). During the 72 hours after the first surfactant dose, the average FIO2 (+/- SEM) was 0.50 +/- 0.01 for Exosurf and 0.42 +/- 0.01 for Survanta (difference, 0.08; 95% confidence interval, 0.05 to 0.11); the average MAP (+/- SEM) was 7.64 +/- 0.21 cm H2O for Exosurf and 6.93 +/- 0.21 cm H2O for Survanta (difference, 0.71 cm H2O; 95% confidence interval, 0.13 to 1.29 cm H2O). There was no difference between the groups in the incidence of other neonatal morbidities or in the duration of hospitalization, assisted ventilation, or supplemental oxygen administration. CONCLUSION: We found no difference between treatment groups in the incidence of death or bronchopulmonary dysplasia, although we did observe a difference in the initial response to treatment as measured by FIO2 and MAP.

Biological Products↗
PubMed1993

Cost effectiveness of beractant in the prevention of respiratory distress syndrome.

Beractant, a modified natural bovine surfactant extract, has been used successfully in the prevention of respiratory distress syndrome (RDS) in premature neonates. This analysis investigates the cost effectiveness of prophylactic surfactant therapy. Resource utilisation data were analysed retrospectively from 210 patients who had participated previously in a double-blind, placebo-controlled clinical trial. No baseline differences were apparent between the beractant and sham-air control groups. There was a significant difference in survival favouring the beractant-treated neonates. When the acquisition cost of the study drug was excluded, there was an incremental, daily cost-savings benefit for the beractant-treated group compared with the sham-air treated group. Costs per case per day were significantly lower for neonates treated with beractant ($US1442 beractant vs $US1544 sham-air; 1991 dollars p = 0.01). Costs for radiological and diagnostic procedures, respiratory care and drugs (excluding beractant) were all significantly lower. When the acquisition cost of beractant was included, the cost to produce a 28-day survivor was $US3319 less with beractant ($US41 020) than with sham-air ($US44 339). Thus, when viewed in terms of costs per year of life saved, beractant compares very favourably with other recently evaluated health technologies.

Cost-Benefit Analysis↗
PubMed1993

Clinical trials of natural surfactant extract in respiratory distress syndrome.

Since the first use of natural surfactant extract by Fujiwara to treat premature infants with respiratory distress syndrome (RDS), multiple randomized controlled clinical trials involving more than 2500 infants have been reported. These trials have used prophylactic administration of surfactant to high-risk premature infants (prevention trials) or administration of surfactant to premature infants with moderate to severe RDS (rescue or treatment trials). This article shows meta-analysis of the trial data, significant effects of natural surfactant extracts, and significant clinical benefits.

Animals↗
PubMed1991

Radiographic findings associated with surfactant treatment.

Radiographs of the chest (CXR) were evaluated in 35 of 41 infants enrolled in a randomized controlled trial of modified bovine surfactant extract (Surfactant-TA Tokyo-Tanabe) treatment. Infants between birthweight 1000 and 1500 gm with respiratory distress syndrome requiring mechanical ventilation and an inspired oxygen concentration 0.4 or greater were randomly assigned to either a single intratracheal dose of saline or surfactant-TA prior to 8 hours of age. Radiographs obtained prior to treatment and 24 hours after treatment were reviewed by a radiologist (N.T.G.) without knowledge of treatment group. Evaluation consisted of a score including criteria for inflation of the lungs, density of the lungs, and extent of air bronchograms. Pneumothorax, pulmonary interstitial emphysema, and asymmetric parenchymal involvement were noted as well. No significant difference in CXR scores were noted in the two groups, before or after treatment. There was a greater incidence of pneumothorax and pulmonary interstitial emphysema in the control infants, which supports the role of surfactant in preventing barotrauma. Increased incidence of asymmetric parenchymal involvement was noted in the surfactant-treated infants. Further study of the possibility of drug maldistribution is warranted.

Female↗