The Journal of pediatrics
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The Journal of pediatrics · Jul 1991
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialMulticenter controlled trial comparing high-frequency jet ventilation and conventional mechanical ventilation in newborn infants with pulmonary interstitial emphysema.
One hundred forty-four newborn infants with pulmonary interstitial emphysema were stratified by weight and severity of illness, and randomly assigned to receive treatment with high-frequency jet ventilation (HFJV) or rapid-rate conventional mechanical ventilation (CV) with short inspiratory time. If criteria for treatment failure were met, crossover to the alternate ventilatory mode was permitted. Overall, 45 (61%) of 74 infants met treatment success criteria with HFJV compared with 26 (37%) of 70 treated with CV (p less than 0.01). ⋯ When survival resulting from rescue by the alternate therapy in crossover patients was excluded, the survival rate was 64.9% for HFJV, compared with 47.1% for CV (p less than 0.05). The incidence of chronic lung disease, intraventricular hemorrhage, patent ductus arteriosus, airway obstruction, and new air leak was similar in both groups. We conclude that HFJV, as used in this study, is safe and is more effective than rapid-rate CV in the treatment of newborn infants with pulmonary interstitial emphysema.
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The Journal of pediatrics · Apr 1991
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialRandomized, placebo-controlled trial of human surfactant given at birth versus rescue administration in very low birth weight infants with lung immaturity.
A randomized, placebo-controlled trial of human surfactant given intratracheally at birth (prophylactic) versus rescue administration after the onset of severe respiratory distress syndrome (RDS) was conducted among preterm infants born at 24 to 29 weeks of gestation. Singleton fetuses were randomly assigned to receive (1) placebo (air), (2) prophylactic surfactant treatment, or (3) rescue surfactant treatment; infants of multiple births received either (1) prophylactic or (2) rescue treatment. Of 282 potentially eligible fetuses, 246 infants received treatments at birth and 200 infants had RDS. ⋯ Among infants with RDS, the total mortality rate was significantly improved (p = 0.004) with surfactant treatment but not the proportion alive and without bronchopulmonary dysplasia at 28 days (p = 0.052), or the proportion alive and without bronchopulmonary dysplasia at 38 weeks of postconceptional age (p = 0.18) to adjust for differences in prematurity. Deaths caused by RDS or bronchopulmonary dysplasia were significantly reduced among surfactant recipients (p = 0.0001). Neither among singletons nor among multiple-birth infants was there a selective advantage to prophylactic versus rescue treatment.(ABSTRACT TRUNCATED AT 400 WORDS)
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The Journal of pediatrics · Apr 1991
Randomized Controlled Trial Multicenter Study Clinical TrialEffects of two rescue doses of a synthetic surfactant on mortality rate and survival without bronchopulmonary dysplasia in 700- to 1350-gram infants with respiratory distress syndrome. The American Exosurf Neonatal Study Group I.
In a multicenter, double-blind, placebo-controlled rescue trial conducted at 21 American hospitals, two 5 ml/kg doses of a synthetic surfactant (Exosurf Neonatal) or air were administered to 419 infants weighing 700 to 1350 gm who had respiratory distress syndrome and an arterial/alveolar oxygen pressure ratio less than 0.22. The first dose was given between 2 and 24 hours of age; the second dose was given 12 hours later to those infants remaining on ventilatory support. Infants were stratified at entry by birth weight and gender. ⋯ In addition, the incidence of pneumothorax was reduced by one third (62 vs 40; p = 0.022), and the incidence of pulmonary interstitial emphysema was reduced by half (102 vs 51; p = 0.001). The only side effect identified was an increase in the incidence of apnea (102 vs 134; p = 0.001). These findings indicate that rescue use of a synthetic surfactant can improve the morbidity and mortality rates for premature infants with respiratory distress syndrome.
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The Journal of pediatrics · Jun 1990
Multicenter Study Comparative Study Clinical Trial Controlled Clinical TrialHigh-frequency oscillatory ventilation compared with conventional mechanical ventilation in the treatment of respiratory failure in preterm infants: assessment of pulmonary function at 9 months of corrected age. HiFi Study Group.
In a comparison of the outcome of high-frequency oscillatory ventilation (HFO) and conventional mechanical ventilation (intermittent mandatory ventilation (IMV] in newborn infants, the degree of late pulmonary damage in these infants was assessed in a multicenter trial by examining their pulmonary status, including pulmonary function test results at 9 months of corrected age. A total of 432 infants were followed, 222 in the IMV group and 210 in the HFO group. Two-hundred twenty-three infants had their pulmonary mechanics measured, 118 in the IMV group and 105 in the HFO group. ⋯ Forced expiratory flow at functional residual capacity was decreased (132 +/- 86 vs 135 +/- 92 ml/sec in the IMV and HFO groups, respectively), peak-to-peak esophageal pressure change was elevated (14.4 +/- 5.7 vs 13.5 +/- 5.7 cm H2O), dynamic compliance was in the low normal range (1.2 +/- 0.5 vs 1.3 +/- 0.6 ml/cm H2O/kg), and total pulmonary resistance was elevated (63 +/- 43 vs 57 +/- 34 cm H2O/L/sec) when the measurements were compared with normal values. The results indicate that in both groups, 30% to 40% of infants survived with chronic pulmonary changes similar to those described in infants with bronchopulmonary dysplasia. The use of high-frequency ventilation, in comparison with IMV, did not improve long-term pulmonary outcome.