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Objective. Current guidelines of the Accreditation Council for Graduate Medical Education have restricted the amount of intensive care experience obtained during pediatric residency. The impact on performing procedures has not been evaluated. To determine the current level of competency in 1 common procedure, we investigated the proficiency of pediatric residents in performing neonatal endotracheal intubation during the academic years 1998–1999 and 2000–2001. Methods. Indication for intubation, number of attempts, and achievement of success were recorded by the respiratory therapist present for the procedure. Each intubation was scored according to the attempt on which intubation was successful. Indications for intubation were categorized as respiratory failure, delivery room resuscitation, and meconium-stained amniotic fluid. Competency was defined as a successful intubation occurring on the first or second attempt ≥80% of the time. Intubation scores were compared between residents at various stages of training and analyzed by multivariate logistic regression analysis for significance. Comparisons were then performed to determine percentage success with confidence intervals. We also surveyed previous graduates of the training program not included in the observations for this study and asked them to indicate how frequently they perform intubation in current practice and to assess their own competence in the procedure. Results. A total of 449 resident procedures were observed during the study periods: 192 by postgraduate year 1 (PGY-1) residents, 126 by PGY-2 residents, and 131 by PGY-3 residents. A total of 35% (160 of 449) of intubation procedures were never successful by pediatric house officers. Intubation was successful on the first or second attempt for 50% of PGY-1 residents (95% confidence interval [CI]: 42.6–56.8), 55% of PGY-2 residents (95% CI: 46–63.5), and 62% of PGY-3 residents (95% CI: 53.9–70.7). The third-year residents exhibited a significantly higher likelihood of performing a successful intubation compared with first-year residents. The first-year residents in 1998–1999 showed no improvement by their third year in 2000–2001. Surveys were sent to 56 graduates of our residency program (1998–2000). Completed surveys were received from 31 (66%) of 47. A total of 71% of the respondents are practicing general pediatrics, and 36% attend deliveries or perform intubations. A total of 87% reported that their level of confidence with endotracheal intubation was good or excellent after completion of residency training. Conclusions. We provide objective and subjective data concerning the proficiency of pediatric residents in performing neonatal endotracheal intubation. None of our resident groups met the specified definition of technical competence, although there was improvement with advancing training level in bivariate analyses. However, graduates of our training program felt confident with their intubation skills in contrast to our objective findings. As exposure to these important skills becomes limited, methods to ensure attainment of technical competency during training may need to be redefined.

Background and objective. Surfactant replacement is a powerful therapy for newborns with respiratory distress syndrome, but limited observations suggest that alterations of cerebral blood flow can accompany the use of several available surfactants. An early European multicenter controlled study with beractant demonstrated an increased rate of intracranial hemorrhage in treated patients. Nine additional controlled studies were subsequently performed and included follow-up evaluations through 2 years adjusted age. This clinical experience provided a database of approximately 1700 infants to examine retrospectively for any relationship between surfactant therapy and intracranial hemorrhage. Methods. Cumulative incidence rates, hazard ratios, and 95% confidence intervals for intracranial hemorrhage were computed for each study and for appropriately pooled studies of similar design. Where an association between surfactant and the risk of intracranial hemorrhage was found, additional analyses were performed to attempt to identify intermediate physiologic events that might link administration of surfactant to the occurrence of intracranial hemorrhage. These analyses were guided by literature reports of hemodynamic changes observed in association with surfactant therapy. Results. During the controlled studies with beractant, treated newborns of 600 to 750 g birth weight were at higher risk for grades I and II intracranial hemorrhage than control newborns. There was no increased risk for grades III and IV hemorrhage among these newborns, nor was there increased risk of hemorrhage among any other patient groups. This finding did not result in increased morbidity for the affected patients; at 2 years adjusted age, they were not different from the control infants of 600 to 750 g birth weight. Retrospective examination of the database could not pinpoint the mechanism behind the finding, but it might have been related to changes in cerebral blood flow after surfactant uncompensated by ventilator management of oxygenation and ventilation. Conclusion. Surfactant therapy may set in motion hemodynamic changes that could predispose to intracranial hemorrhage in certain circumstances, but this can probably be compensated by careful management of oxygenation and ventilation. A relationship between surfactant therapy and intracranial hemorrhage is probably not isolated to any particular surfactant preparation or method of delivery; studies comparing surfactants have shown no differences in rates of intracranial hemorrhage.

From September 1989 through July 1991, before commercial availability, Survanta (beractant intratracheal suspension), a modified bovine-derived surfactant used for prevention and treatment of neonatal respiratory distress syndrome, was made available to 231 neonatal intensive care units in the United States and Canada under a Treatment Investigational New Drug protocol. Results of this open clinical experience are reported. Investigators could give one dose of Survanta soon after birth to neonates weighing 600 to 1250 g (prevention strategy). Neonates weighing 600 to 1750 g who were not treated at birth could begin Survanta therapy if respiratory distress syndrome developed within 8 hours of birth (rescue strategy). All neonates could receive up to three more doses over the first 48 hours of life at minimum intervals of 6 hours if they met retreatment criteria. Qualifications for enrollment closely matched those used in previous randomized controlled clinical trials. This report includes results from 8168 neonates who completed the study. Treatment Investigational New Drug rates for intracranial hemorrhage, patent ductus arteriosus, pulmonary hemorrhage, pulmonary air leaks, bronchopulmonary dysplasia, death or bronchopulmonary dysplasla, pulmonary interstitial emphysema, pretreatment sepsis, and posttreatment sepsis were less than for treated neonates in the controlled trials and survival was equivalent across studies. Problems with treatment administration were reported with 30.4% of doses, while adverse events were reported in 0.5% of neonates. The results of the Treatment Investigational New Drug protocol revealed no new safety concerns associated with the widespread use of Survanta and confirmed the safety profile established in earlier controlled trials.

To determine whether multiple doses of bovine surfactant would improve neonatal mortality in very premature neonates, we conducted two multicenter controlled trials under identical protocols; the results were combined for analysis. Four hundred and thirty neonates born between 23 and 29 weeks gestation and weighing 600 to 1250 g at birth were assigned randomly at birth to receive either 100 mg of phospholipids/kg of Survanta, a modified bovine surfactant (n = 210), or a sham air placebo (n = 220) within 15 minutes of birth. Neonates who developed respiratory distress syndrome and required mechanical ventilation with at least 30% oxygen could be given up to three more doses in the first 48 hours after birth. Dosing was performed by investigators not involved in the clinical care of the neonates; nursery staff were kept blinded as to the treatment assignment. Cause of death was determined by a panel of three independent, board-certified neonatologists after blindly reviewing case report forms and autopsy reports. Fewer Survanta-treated neonates died of any cause (11.4% vs 18.8%, P = .031), died of respiratory distress syndrome (1.9% vs 15.6%, P < .001), and either died or developed bronchopulmonary dysplasia due to respiratory distress syndrome (39.5% vs 49.1%, P = .044). The incidence of respiratory distress syndrome was also lower in Survanta-treated neonates (28.0% vs 56.9%, P < .001), and the Survanta-treated neonates' oxygenation and ventilatory status were improved significantly at 72 hours. Survanta-treated neonates were also at lowered risk of developing pulmonary interstitial emphysema (23.3% vs 36.9%, P = .002) and other forms of pulmonary air leaks (9.6% vs 20.8%, P .002). We conclude that multiple doses of Survanta reduce mortality and morbidity due to respiratory distress syndrome during the neonatal period.

Surfactant replacement is a powerful therapy for newborns with respiratory distress syndrome, but limited observations suggest that alterations of cerebral blood flow can accompany the use of several available surfactants. An early European multicenter controlled study with beractant demonstrated an increased rate of intracranial hemorrhage in treated patients. Nine additional controlled studies were subsequently performed and included follow-up evaluations through 2 years adjusted age. This clinical experience provided a database of approximately 1700 infants to examine retrospectively for any relationship between surfactant therapy and intracranial hemorrhage.Cumulative incidence rates, hazard ratios, and 95% confidence intervals for intracranial hemorrhage were computed for each study and for appropriately pooled studies of similar design. Where an association between surfactant and the risk of intracranial hemorrhage was found, additional analyses were performed to attempt to identify intermediate physiologic events that might link administration of surfactant to the occurrence of intracranial hemorrhage. These analyses were guided by literature reports of hemodynamic changes observed in association with surfactant therapy.During the controlled studies with beractant, treated newborns of 600 to 750 g birth weight were at higher risk for grades I and II intracranial hemorrhage than control newborns. There was no increased risk for grades III and IV hemorrhage among these newborns, nor was there increased risk of hemorrhage among any other patient groups. This finding did not result in increased morbidity for the affected patients; at 2 years adjusted age, they were not different from the control infants of 600 to 750 g birth weight. Retrospective examination of the database could not pinpoint the mechanism behind the finding, but it might have been related to changes in cerebral blood flow after surfactant uncompensated by ventilator management of oxygenation and ventilation.Surfactant therapy may set in motion hemodynamic changes that could predispose to intracranial hemorrhage in certain circumstances, but this can probably be compensated by careful management of oxygenation and ventilation. A relationship between surfactant therapy and intracranial hemorrhage is probably not isolated to any particular surfactant preparation or method of delivery; studies comparing surfactants have shown no differences in rates of intracranial hemorrhage.

From September 1989 through July 1991, before commercial availability, Survanta (beractant intratracheal suspension), a modified bovine-derived surfactant used for prevention and treatment of neonatal respiratory distress syndrome, was made available to 231 neonatal intensive care units in the United States and Canada under a Treatment Investigational New Drug protocol. Results of this open clinical experience are reported. Investigators could give one dose of Survanta soon after birth to neonates weighing 600 to 1250 g (prevention strategy). Neonates weighing 600 to 1750 g who were not treated at birth could begin Survanta therapy if respiratory distress syndrome developed within 8 hours of birth (rescue strategy). All neonates could receive up to three more doses over the first 48 hours of life at minimum intervals of 6 hours if they met retreatment criteria. Qualifications for enrollment closely matched those used in previous randomized controlled clinical trials. This report includes results from 8168 neonates who completed the study. Treatment Investigational New Drug rates for intracranial hemorrhage, patent ductus arteriosus, pulmonary hemorrhage, pulmonary air leaks, bronchopulmonary dysplasia, death or bronchopulmonary dysplasia, pulmonary interstitial emphysema, pretreatment sepsis, and posttreatment sepsis were less than for treated neonates in the controlled trials and survival was equivalent across studies. Problems with treatment administration were reported with 30.4% of doses, while adverse events were reported in 0.5% of neonates. The results of the Treatment Investigational New Drug protocol revealed no new safety concerns associated with the widespread use of Survanta and confirmed the safety profile established in earlier controlled trials.

To determine whether multiple doses of bovine surfactant would improve neonatal mortality in very premature neonates, we conducted two multicenter controlled trials under identical protocols; the results were combined for analysis. Four hundred and thirty neonates born between 23 and 29 weeks gestation and weighing 600 to 1250 g at birth were assigned randomly at birth to receive either 100 mg of phospholipids/kg of Survanta, a modified bovine surfactant (n = 210), or a sham air placebo (n = 220) within 15 minutes of birth. Neonates who developed respiratory distress syndrome and required mechanical ventilation with at least 30% oxygen could be given up to three more doses in the first 48 hours after birth. Dosing was performed by investigators not involved in the clinical care of the neonates; nursery staff were kept blinded as to the treatment assignment. Cause of death was determined by a panel of three independent, board-certified neonatologists after blindly reviewing case report forms and autopsy reports. Fewer Survanta-treated neonates died of any cause (11.4% vs 18.8%, P = .031), died of respiratory distress syndrome (1.9% vs 15.6%, P less than .001), and either died or developed bronchopulmonary dysplasia due to respiratory distress syndrome (39.5% vs 49.1%, P = .044). The incidence of respiratory distress syndrome was also lower in Survanta-treated neonates (28.0% vs 56.9%, P less than .001), and the Survanta-treated neonates' oxygenation and ventilatory status were improved significantly at 72 hours. Survanta-treated neonates were also at lowered risk of developing pulmonary interstitial emphysema (23.3% vs 36.9%, P = .002) and other forms of pulmonary air leaks (9.6% vs 20.8%, P .002).(ABSTRACT TRUNCATED AT 250 WORDS)

In Reply.— In answering Dr Kattwinkel's letter, I asked for help from two physicians intimately involved in the commercial development of Survanta and Exosurf. Their replies follow: The author of this letter offers a counterpoint to Dr Lucey's editorial. An exchange of views is usually healthy and consistent with the scientific method. However, in some cases his views are incorrect and misinformed. On one thing we agree; surfactant therapy "works and is safe." "Getting there" has been a long and arduous process.