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Waldemar A Carlo

Publications and source records attributed to Waldemar A Carlo.

At least 19 recordsLinked to original sources

Fetal growth risk curves: defining levels of fetal growth restriction by neonatal death risk.

OBJECTIVE: We developed a fetal growth risk curve that delineates the birth weight values for gestational age that reflect a 2-, 2.5-, and 3-fold neonatal death risk relative to infants with normal fetal growth. STUDY DESIGN: We analyzed 18,085,052 single gestation infants (25-42 weeks) who were born to US resident mothers from 1996 to 2000. Multivariate models were used to predict the relationship between neonatal death and birth weight percentile. Fetal risk curves were derived on the basis of birth weight percentile-specific neonatal mortality rates that were relative to an average rate of neonatal death for a comparison group that was representative of typical growth (ie, infants between 45th-55th birth weight percentiles for gestational age). RESULTS: The 10th percentile of birth weight for gestational age is associated with an increased but variable risk of neonatal death relative to the comparison group across the spectrum of gestational ages. At 26 weeks of gestation, infants at the 10th percentile experienced a 3-fold risk of dying within the first 28 days of life (relative to the comparison group); whereas at 40 weeks, the risk was 1.13. CONCLUSION: Fetal growth risk curves facilitate the identification of populations of infants whose risk of death are deemed excessive compared with that of infants at the norm of fetal growth and may be useful for counseling pregnant women.

Birth Weight↗

Outcome of extremely preterm infants randomized at birth to different PaCO2 targets during the first seven days of life.

BACKGROUND: Ventilation with higher PaCO(2) goals may reduce lung injury and bronchopulmonary dysplasia (BPD). The effect may be enhanced by using a higher PaCO(2) goal than in previous trials. OBJECTIVE: To determine the clinical benefits and safety of higher PaCO(2) goals for ventilated preterm infants. STUDY DESIGN: Preterm infants with a gestational age between 23 and 28 completed weeks receiving mechanical ventilation within 6 h of birth were randomized to be managed with either a PaCO(2) target between 55 and 65 mm Hg (7.3- 8.7 kPa, minimal ventilation) or 35 and 45 mm Hg (4.7- 6.0 kPa, routine ventilation) for the first 7 days of life. The primary outcome measure was BPD, defined as need for mechanical ventilation or supplemental oxygen at 36 weeks postmenstrual age, or death. The neurodevelopmental status was assessed at 18-22 months corrected age. RESULTS: The trial was stopped early after enrolling 31% of the projected sample size. Enrolled infants had a median birth weight of 640 g. BPD or death occurred in 21/33 (64%) infants after minimal ventilation and 19/32 (59%) infants after routine ventilation. Minimal ventilation was associated with trends towards higher mortality and higher incidence of neurodevelopmental impairment, and a significantly increased combined outcome of mental impairment or death (p < 0.05). CONCLUSION: Minimal ventilation as performed in this study did not improve clinical outcome, and may have been associated with a worse neurodevelopmental outcome.

Algorithms↗

The role of carbon dioxide detectors for confirmation of endotracheal tube position.

There is evidence that practitioners who are responsible for airway management at newborn resuscitations may place an endotracheal tube incorrectly with confidence. Moving on to the further stages of resuscitation, without managing the airway adequately, and commencing ventilation has the potential for significant harm to the baby. Because primary confirmation is fallible, there is a need for secondary confirmation of correct endotracheal tube placement and effective airway and breathing before moving on to cardiovascular support. Symmetric chest movement, auscultation, exhaled carbon dioxide (CO(2)), and an increase in heart rate have been suggested as providing secondary confirmation. Measurement of exhaled CO(2) is accepted widely as a standard of care in adult and pediatric intensive care and in anaesthetized patients.

Capnography↗

Ventilatory strategies in the prevention and management of bronchopulmonary dysplasia.

Bronchopulmonary dysplasia (BPD) leads to considerable mortality and morbidity in premature infants. Although mechanical ventilation is lifesaving in infants with respiratory distress syndrome (RDS), it may contribute to lung injury and subsequently to BPD. Appropriate ventilatory strategies for reducing BPD include redefining the goals for "adequate gas exchange," using less mechanical ventilation support, refining the methods of mechanical ventilation, and using alternative techniques. Permissive hypercapnia, permissive hypoxemia, minimal peak pressures, rapid rates, early therapeutic continuous positive airway pressure (CPAP), and rapid extubation may help reduce mechanical ventilation-induced lung injury and possibly reduce BPD. Newer techniques of ventilation such as volume-targeted ventilation are also promising. High frequency ventilation has not been proven to reduce BPD. There is a lack of evidence-based guidelines on management of infants with established BPD. Optimization of clinical care practices and ancillary therapies need to be combined with ventilatory strategies to prevent and manage BPD.

Bronchopulmonary Dysplasia↗

Predicting outcomes of neonates diagnosed with hypoxemic-ischemic encephalopathy.

OBJECTIVE: The goals were to identify predictor variables and to develop scoring systems and classification trees to predict death/disability or death in infants with hypoxic-ischemic encephalopathy. METHODS: Secondary analysis of data from the multicenter, randomized, controlled, National Institute of Child Health and Human Development Neonatal Research Network trial of hypothermia in hypoxic-ischemic encephalopathy was performed. Data for 205 neonates diagnosed as having hypoxic-ischemic encephalopathy were studied. Logistic regression analysis was performed by using clinical and laboratory variables available within 6 hours of birth, with death or moderate/severe disability at 18 to 22 months or death as the outcomes. By using the identified variables and odds ratios, scoring systems to predict death/disability or death were developed, weighting each predictor in proportion to its odds ratio. In addition, classification and regression tree analysis was performed, with recursive partitioning and automatic selection of optimal cutoff points for variables. Correct classification rates for the scoring systems, classification and regression tree models, and early neurologic examination were compared. RESULTS: Correct classification rates were 78% for death/disability and 71% for death with the scoring systems, 80% and 77%, respectively, with the classification and regression tree models, and 67% and 73% with severe encephalopathy in early neurologic examination. Correct classification rates were similar in the hypothermia and control groups. CONCLUSIONS: Among neonates diagnosed as having hypoxic-ischemic encephalopathy, the classification and regression tree model, but not the scoring system, was superior to early neurologic examination in predicting death/disability. The 3 models were comparable in predicting death. Only a few components of the early neurologic examination were associated with poor outcomes. These scoring systems and classification trees, if validated, may help in assessments of prognosis and may prove useful for risk-stratification of infants with hypoxic-ischemic encephalopathy for clinical trials.

Algorithms↗

Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy.

BACKGROUND: Hypothermia is protective against brain injury after asphyxiation in animal models. However, the safety and effectiveness of hypothermia in term infants with encephalopathy is uncertain. METHODS: We conducted a randomized trial of hypothermia in infants with a gestational age of at least 36 weeks who were admitted to the hospital at or before six hours of age with either severe acidosis or perinatal complications and resuscitation at birth and who had moderate or severe encephalopathy. Infants were randomly assigned to usual care (control group) or whole-body cooling to an esophageal temperature of 33.5 degrees C for 72 hours, followed by slow rewarming (hypothermia group). Neurodevelopmental outcome was assessed at 18 to 22 months of age. The primary outcome was a combined end point of death or moderate or severe disability. RESULTS: Of 239 eligible infants, 102 were assigned to the hypothermia group and 106 to the control group. Adverse events were similar in the two groups during the 72 hours of cooling. Primary outcome data were available for 205 infants. Death or moderate or severe disability occurred in 45 of 102 infants (44 percent) in the hypothermia group and 64 of 103 infants (62 percent) in the control group (risk ratio, 0.72; 95 percent confidence interval, 0.54 to 0.95; P=0.01). Twenty-four infants (24 percent) in the hypothermia group and 38 (37 percent) in the control group died (risk ratio, 0.68; 95 percent confidence interval, 0.44 to 1.05; P=0.08). There was no increase in major disability among survivors; the rate of cerebral palsy was 15 of 77 (19 percent) in the hypothermia group as compared with 19 of 64 (30 percent) in the control group (risk ratio, 0.68; 95 percent confidence interval, 0.38 to 1.22; P=0.20). CONCLUSIONS: Whole-body hypothermia reduces the risk of death or disability in infants with moderate or severe hypoxic-ischemic encephalopathy.

Acidosis↗

Inhaled nitric oxide for premature infants with severe respiratory failure.

BACKGROUND: Inhaled nitric oxide is a controversial treatment for premature infants with severe respiratory failure. We conducted a multicenter, randomized, blinded, controlled trial to determine whether inhaled nitric oxide reduced the rate of death or bronchopulmonary dysplasia in such infants. METHODS: We randomly assigned 420 neonates, born at less than 34 weeks of gestation, with a birth weight of 401 to 1500 g, and with respiratory failure more than four hours after treatment with surfactant to receive placebo (simulated flow) or inhaled nitric oxide (5 to 10 ppm). Infants with a response (an increase in the partial pressure of arterial oxygen of more than 10 mm Hg) were weaned according to protocol. Treatment with study gas was discontinued in infants who did not have a response. RESULTS: The rate of death or bronchopulmonary dysplasia was 80 percent in the nitric oxide group, as compared with 82 percent in the placebo group (relative risk, 0.97; 95 percent confidence interval, 0.86 to 1.06; P=0.52), and the rate of bronchopulmonary dysplasia was 60 percent versus 68 percent (relative risk, 0.90; 95 percent confidence interval, 0.75 to 1.08; P=0.26). There were no significant differences in the rates of severe intracranial hemorrhage or periventricular leukomalacia. Post hoc analyses suggest that rates of death and bronchopulmonary dysplasia are reduced for infants with a birth weight greater than 1000 g, whereas infants weighing 1000 g or less who are treated with inhaled nitric oxide have higher mortality and increased rates of severe intracranial hemorrhage. CONCLUSIONS: The use of inhaled nitric oxide in critically ill premature infants weighing less than 1500 g does not decrease the rates of death or bronchopulmonary dysplasia. Further trials are required to determine whether inhaled nitric oxide benefits infants with a birth weight of 1000 g or more.

Administration, Inhalation↗

Vitamin A supplementation for extremely low birth weight infants: outcome at 18 to 22 months.

BACKGROUND: A National Institute of Child Health and Human Development Neonatal Research Network randomized trial showed that vitamin A supplementation reduced bronchopulmonary dysplasia (O2 at 36 weeks' postmenstrual age) or death in extremely low birth weight (ELBW) neonates (relative risk [RR]: 0.89). As with postnatal steroids or other interventions, it is important to ensure that there are no longer-term adverse effects that outweigh neonatal benefits. PRIMARY OBJECTIVE: To determine if vitamin A supplementation in ELBW infants during the first month after birth affects survival without neurodevelopmental impairment at a corrected age of 18 to 22 months. DESIGN/METHODS: Infants enrolled in the National Institute of Child Health and Human Development vitamin A trial were evaluated at 18 to 22 months by carefully standardized assessments: Bayley Mental Index (MDI) and Psychomotor Index (PDI), visual and hearing screens, and physical examination for cerebral palsy (CP). The medical history was also obtained. Neurodevelopmental impairment (NDI) was predefined as > or =1 of MDI <70, PDI <70, CP, blind in both eyes, or hearing aids in both ears. RESULTS: Of 807 enrolled infants, 133 died before and 16 died after discharge. Five hundred seventy-nine (88%) of the 658 remaining infants were followed up. The primary outcome of NDI or death could be determined for 687 of 807 randomized infants (85%). Baseline characteristics and predischarge and postdischarge mortality were comparable in both study groups. NDI or death by 18 to 22 months occurred in 190 of 345 (55%) infants in the vitamin A group and in 204 of 342 (60%) of the control group (RR: 0.94; 95% confidence interval: 0.80-1.07). RRs for low MDI, low PDI, and CP were also <1.0. We found no evidence that neonatal vitamin A supplementation reduces hospitalizations or pulmonary problems after discharge. CONCLUSION: Vitamin A supplementation for ELBW infants reduces bronchopulmonary dysplasia without increasing mortality or neurodevelopmental impairment at 18 to 22 months. However, this study was not powered to evaluate small magnitudes of change in long-term outcomes.

Bronchopulmonary Dysplasia↗

Analgesia and anesthesia for neonates: study design and ethical issues.

OBJECTIVE: The purpose of this article is to summarize the clinical, methodologic, and ethical considerations for researchers interested in designing future trials in neonatal analgesia and anesthesia, hopefully stimulating additional research in this field. METHODS: The MEDLINE, PubMed, EMBASE, and Cochrane register databases were searched using subject headings related to infant, newborn, neonate, analgesia, anesthesia, ethics, and study design. Cross-references and personal files were searched manually. Studies reporting original data or review articles related to these topics were assessed and critically evaluated by experts for each topical area. Data on population demographics, study characteristics, and cognitive and behavioral outcomes were abstracted and synthesized in a systematic manner and refined by group members. Data synthesis and results were reviewed by a panel of independent experts and presented to a wider audience including clinicians, scientists, regulatory personnel, and industry representatives at the Newborn Drug Development Initiative workshop. Recommendations were revised after extensive discussions at the workshop and between committee members. RESULTS: Designing clinical trials to investigate novel or currently available approaches for analgesia and anesthesia in neonates requires consideration of salient study designs and ethical issues. Conditions requiring treatment include pain/stress resulting from invasive procedures, surgical operations, inflammatory conditions, and routine neonatal intensive care. Study design considerations must define the inclusion and exclusion criteria, a rationale for stratification, the confounding effects of comorbid conditions, and other clinical factors. Significant ethical issues include the constraints of studying neonates, obtaining informed consent, making risk-benefit assessments, defining compensation or rewards for participation, safety considerations, the use of placebo controls, and the variability among institutional review boards in interpreting federal guidelines on human research. For optimal study design, investigators must formulate well-defined study questions, choose appropriate trial designs, estimate drug efficacy, calculate sample size, determine the duration of the studies, identify pharmacokinetic and pharmacodynamic parameters, and avoid drug-drug interactions. Specific outcome measures may include scoring on pain assessment scales, various biomarkers and their patterns of response, process outcomes (eg, length of stay, time to extubation), intermediate or long-term outcomes, and safety parameters. CONCLUSIONS: Much more research is needed in this field to formulate a scientifically sound, evidence-based, and clinically useful framework for management of anesthesia and analgesia in neonates. Newer study designs and additional ethical dilemmas may be defined with accumulating data in this field.

Analgesia↗

Retinol-binding protein, transthyretin, and C-reactive protein in extremely low birth weight (ELBW) infants.

BACKGROUND: Vitamin A deficiency reduces retinol binding protein (RBP) but not transthyretin (TTR), while inflammation reduces both RBP and TTR and increases C-reactive protein (CRP), an acute phase reactant. OBJECTIVE: To estimate serum RBP, TTR, and CRP in ELBW infants to test the hypotheses that (a) TTR is a negative acute phase reactant and (b) a higher RBP/TTR ratio or CRP is associated with death/BPD by 36 weeks corrected age. DESIGN/METHODS: Serum RBP, TTR, and CRP were measured in 79 ELBW infants at 28 days. Area under the curve (AUC) of receiver operating characteristic curve analysis evaluated the predictive value of TTR, the RBP/TTR ratio, and CRP for death/BPD at 36 weeks. RESULTS: (1) TTR inversely correlated with CRP (r=-0.45, p<0.0001) consistent with TTR being a negative acute phase reactant. (2) The RBP/TTR ratio predicted death/BPD (AUC 0.68 (CI 0.57 to 0.78)). (3) CRP strongly predicted death/BPD (AUC 0.85 (CI 0.76 to 0.92)), even after exclusion of sepsis. CONCLUSIONS: A higher CRP and RBP/TTR molar ratio on day 28 are associated with death/BPD at 36 weeks in ELBW infants. Lower TTR and maintained RBP/TTR ratios suggest inflammation rather than vitamin A deficiency as the cause for lower serum vitamin A levels in ELBW infants..

Area Under Curve↗

Prediction of death for extremely low birth weight neonates.

OBJECTIVE: To compare multiple logistic regression and neural network models in predicting death for extremely low birth weight neonates at 5 time points with cumulative data sets, as follows: scenario A, limited prenatal data; scenario B, scenario A plus additional prenatal data; scenario C, scenario B plus data from the first 5 minutes after birth; scenario D, scenario C plus data from the first 24 hours after birth; scenario E, scenario D plus data from the first 1 week after birth. METHODS: Data for all infants with birth weights of 401 to 1000 g who were born between January 1998 and April 2003 in 19 National Institute of Child Health and Human Development Neonatal Research Network centers were used (n = 8608). Twenty-eight variables were selected for analysis (3 for scenario A, 15 for scenario B, 20 for scenario C, 25 for scenario D, and 28 for scenario E) from those collected routinely. Data sets censored for prior death or missing data were created for each scenario and divided randomly into training (70%) and test (30%) data sets. Logistic regression and neural network models for predicting subsequent death were created with training data sets and evaluated with test data sets. The predictive abilities of the models were evaluated with the area under the curve of the receiver operating characteristic curves. RESULTS: The data sets for scenarios A, B, and C were similar, and prediction was best with scenario C (area under the curve: 0.85 for regression; 0.84 for neural networks), compared with scenarios A and B. The logistic regression and neural network models performed similarly well for scenarios A, B, D, and E, but the regression model was superior for scenario C. CONCLUSIONS: Prediction of death is limited even with sophisticated statistical methods such as logistic regression and nonlinear modeling techniques such as neural networks. The difficulty of predicting death should be acknowledged in discussions with families and caregivers about decisions regarding initiation or continuation of care.

Female↗

Bronchopulmonary dysplasia: new insights.

The pathology of BPD has changed over time, with the old BPD characterized by airway injury, inflammation, and parenchymal fibrosis giving way to the new BPD manifesting less fibrosis but with decreased alveolar and vascular development. The pathogenesis of BPD involves factors affecting the severity and management of RDS, alterations in lung development and maturation, alveolar-vascular interactions, and extracellular matrix remodeling. These factors in pathogenesis are mediated and modulated by hyperoxic lung injury, antioxidants, NO, the pulmonary neuroendocrine system and peptide growth factors, the immune system, and various genetic polymorphisms and predispositions. Future therapeutic interventions are likely to target one or more of these abnormalities in lung development, maturation, and response to injury.

Bronchopulmonary Dysplasia↗

Survey of vitamin A supplementation for extremely-low-birth-weight infants: is clinical practice consistent with the evidence?

OBJECTIVE: To survey the attitudes and practices among level III neonatal intensive care units in the United States regarding vitamin A supplementation for extremely-low-birth-weight (ELBW; birth weight < or =1000 g) infants. Study design A pretested questionnaire regarding vitamin A supplementation was distributed to all (n=102) neonatal-perinatal training program directors (TPD) and 105 randomly selected directors of level III neonatal intensive care units (nontraining program directors, NTPD). RESULTS: Ninety-nine percent of TPD and 94% of NTPD responded. In a minority of programs (20% TPD, 13% NTPD), >90% of eligible extremely-low-birth-weight neonates are supplemented with vitamin A, whereas in most programs (69% TPD, 82% NTPD), routine supplementation is not practiced. Most centers (91% TPD, 81% NTPD) supplementing vitamin A use a dose of 5000 IU IM 3 times per week for 4 weeks. The most common reason that TPD give for not supplementing vitamin A is the perceived small benefit, whereas the most common reason for NTPD is that they consider the intervention unproven. CONCLUSIONS: These findings indicate inconsistency in practicing evidence-based medicine in neonatal practice, where therapies are often administered on the basis of weaker evidence of safety and benefit than supports vitamin A supplementation. Educational interventions may be required to endorse the benefits and safety of vitamin A supplementation.

Attitude of Health Personnel↗

Gastric residuals and their relationship to necrotizing enterocolitis in very low birth weight infants.

OBJECTIVE: To determine the characteristics of gastric residuals in very low birth weight (VLBW; <or=1500 g birth weight) infants with and without necrotizing enterocolitis (NEC). METHODS: Case-control study compared 51 VLBW infants who had proven NEC (pneumatosis intestinalis, portal venous gas, and/or perforation; excluding spontaneous gastrointestinal perforations) with 102 control subjects (without suspected or proven NEC) who were matched for birth weight, gestational age, race, and sex and were born January 1996 to December 2001. The age in days at diagnosis of NEC was identified in infants with NEC, and feeding characteristics were recorded for the previous 6 days. Feeding characteristics were recorded for control subjects for the corresponding time period. RESULTS: The median birth weight was 822 g and median gestational age was 26 weeks in both groups. Feeds were started on the fifth day, with a planned increase to full feeds over 10 days (median) in both groups. Median time to full feeds was 13 days in both groups. Median age of onset of NEC was day 24. The total residuals as a percentage of total feed volume (the primary outcome), maximum residual in the previous 6 days, maximum residual as a percentage of the feed, maximum residuals over the 6 days, and the percentage of feeds with residuals were higher in the NEC group. The maximum residual (median [25th-75th centiles]) was as follows: control subjects: 2 mL per feed (0.5-3.5) or 14% of a feed (4-33); NEC group: 4.5 mL per feed (1.5-9.8) or 40% of a feed (24-61). The total residuals as percentage of feeds and the average of maximum residuals increased in the NEC group from the first 3 days to the 3 days before diagnosis of NEC, but a similar increase was not noted for control subjects. CONCLUSIONS: VLBW infants who developed NEC had more gastric residuals. However, there was overlap with the normal control subjects. Of the gastric residual data, the maximum residual seems to be the best predictor for NEC in the subsequent days.

Birth Weight↗

To tap or not to tap: high likelihood of meningitis without sepsis among very low birth weight infants.

CONTEXT: Neonatal meningitis is associated with significant morbidity and mortality. We speculated that meningitis may be underdiagnosed among very low birth weight (VLBW) infants because of the failure to perform lumbar punctures (LPs) in infants with suspected sepsis. OBJECTIVE: This study was undertaken to review the epidemiology of late-onset meningitis in VLBW (401-1500 g) infants and to evaluate the concordance of cerebrospinal fluid (CSF) and blood culture (BC) results. METHODS: VLBW infants (excluding those with intraventricular shunts) born at centers of the National Institute of Child Health and Human Development Neonatal Research Network from September 1, 1998, through December 31, 2001, were studied. Late-onset meningitis was defined by culture-based criteria and classified as meningitis with or without associated sepsis. Unadjusted comparisons were made using chi2 tests and adjusted comparisons using regression models. RESULTS: Of 9641 VLBW infants who survived >3 days, 2877 (30%) had > or = 1 LPs, and 6056 (63%) had > or = 1 BC performed after day 3. One hundred thirty-four infants had late-onset meningitis (1.4% of all patients; 5% of those with an LP). Pathogens associated with meningitis were similar to those associated with sepsis. One third (45 of 134) of the infants with meningitis had negative BCs. Lower gestational age and prior sepsis increased risk for meningitis. Compared with uninfected infants, those with meningitis had a longer time on mechanical ventilation (28 vs 18 days), had longer hospitalizations (91 vs 79 days), were more likely to have seizures (25% vs 2%), and were more likely to die (23% vs 2%). CONCLUSIONS: Meningitis is a serious complication among VLBW infants, associated with increased severity of illness and risk of death. Of note, one third of the infants with meningitis had meningitis in the absence of sepsis. Because CSF cultures were performed only half as often as BCs, this discordance in blood and CSF culture results suggests that meningitis may be underdiagnosed among VLBW infants.

Humans↗

Parenteral glutamine supplementation does not reduce the risk of mortality or late-onset sepsis in extremely low birth weight infants.

BACKGROUND: Glutamine is one of the most abundant amino acids in both plasma and human milk, yet it is not included in standard intravenous amino acid solutions. Previous studies have suggested that parenteral nutrition (PN) supplemented with glutamine may reduce sepsis and mortality in critically ill adults. Whether glutamine supplementation would provide a similar benefit to extremely low birth weight (ELBW) infants is not known. METHODS: We performed a multicenter, randomized, double-masked, clinical trial to assess the safety and efficacy of early PN supplemented with glutamine in decreasing the risk of death or late-onset sepsis in ELBW infants. Infants 401 to 1000 g were randomized within 72 hours of birth to receive either TrophAmine (control) or an isonitrogenous study amino acid solution with 20% glutamine whenever they received PN up to 120 days of age, death, or discharge from the hospital. The primary outcome was death or late-onset sepsis. RESULTS: Of the 721 infants who were assigned to glutamine supplementation, 370 (51%) died or developed late-onset sepsis, as compared with 343 of the 712 infants (48%) assigned to control (relative risk: 1.07; 95% confidence interval: 0.97-1.17). Glutamine had no effect on tolerance of enteral feeds, necrotizing enterocolitis, or growth. No significant adverse events were observed with glutamine supplementation. CONCLUSIONS: Parenteral glutamine supplementation as studied did not decrease mortality or the incidence of late-onset sepsis in ELBW infants. Consequently, although no harm was demonstrated, routine use of parenteral glutamine supplementation cannot be recommended in this population.

Dietary Supplements↗

Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial.

OBJECTIVE: Although earlier studies have suggested that early continuous airway positive pressure (CPAP) may be beneficial in reducing ventilator dependence and subsequent chronic lung disease in the extremely low birth weight (ELBW) infant, the time of initiation of CPAP has varied, and there are no prospective studies of infants who have received CPAP or positive end-expiratory pressure (PEEP) from initial resuscitation in the delivery room (DR). Current practice for the ELBW infant includes early intubation and the administration of prophylactic surfactant, often in the DR. The feasibility of initiating CPAP in the DR and continuing this therapy without intubation for surfactant has never been determined prospectively in a population of ELBW infants. This study was designed to determine the feasibility of randomizing ELBW infants of <28 weeks' gestation to CPAP/PEEP or no CPAP/PEEP during resuscitation immediately after delivery, avoiding routine DR intubation for surfactant administration, initiating CPAP on neonatal intensive care unit (NICU) admission, and assessing compliance with subsequent intubation criteria. METHODS: Infants who were of <28 weeks' gestation, who were born in 5 National Institute of Child Health and Human Development Neonatal Research Network NICUs from July 2002 to January 2003, and for whom a decision had been made to provide full treatment after birth were randomized to receive either CPAP/PEEP or not using a neonatal T-piece resuscitator (NeoPuff). Infants would not be intubated for the sole purpose of surfactant administration in the DR. After admission to the NICU, all nonintubated infants were placed on CPAP and were to be intubated for surfactant administration only after meeting specific criteria: a fraction of inspired oxygen of >0.3 with an oxygen saturation by pulse oximeter of <90% and/or an arterial oxygen pressure of <45 mm Hg, an arterial partial pressure of carbon dioxide of >55 mm Hg, or apnea requiring bag and mask ventilation. RESULTS: A total of 104 infants were enrolled over a 6-month period: 55 CPAP and 49 control infants. No infant was intubated in the DR for the exclusive purpose of surfactant administration. Forty-seven infants were intubated for resuscitation in the DR: 27 of 55 CPAP infants and 20 of 49 control infants. Only 4 of the 43 infants who had a birth weight of <700 g and 3 of the 37 infants of <25 weeks' gestation were resuscitated successfully without positive pressure ventilation, and no difference was observed between the treatment groups. All infants of 23 weeks' gestation required intubation in the DR, irrespective of treatment group, whereas only 3 (14%) of 21 infants of 27 weeks' required such intubation. For infants who were not intubated in the DR, 36 infants (16 CPAP infants and 20 control infants) were subsequently intubated in the NICU by day 7, in accordance with the protocol. Overall, 80% of studied infants required intubation within the first 7 days of life. The care provided for 52 (95%) of 55 CPAP infants and 43 (88%) of the 49 control infants was in compliance with the study protocol, with an overall compliance of 91%. CONCLUSIONS: This study demonstrated that infants could be randomized successfully to a DR intervention of CPAP/PEEP compared with no CPAP/PEEP, with intubation provided only for resuscitation indications, and subsequent intubation for prespecified criteria. Forty-five percent (47 of 104) of infants <28 weeks' gestation required intubation for resuscitation in the DR. CPAP/PEEP in the DR did not affect the need for intubation at birth or during the subsequent week. Overall, 20% of infants did not need intubation by 7 days of life. This experience should be helpful in facilitating the design of subsequent prospective studies of ventilatory support in ELBW infants.

Bronchopulmonary Dysplasia↗