The Journal of pediatrics
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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 · Apr 1991
Body composition, nutrition, and fluid balance during the first two weeks of life in preterm neonates weighing less than 1500 grams.
To determine whether body weight during the first 2 weeks of life in preterm infants weighing less than 1500 gm reflects nutritional status or fluid balance, we studied total body water (TBW) (deuterium oxide dilution), extracellular volume (sucrose dilution), and plasma volume (Evans blue dilution), together with intake-output studies of nitrogen, fluid, and sodium on day 1 (median age 0.3 day), at a weight loss of 7.8% of birth weight (median age 3.4 days), and after birth weight was regained (median age 8.9 days) in eight clinically stable preterm infants (birth weight 810 to 1310 gm, gestational age 26 to 30 weeks) receiving ventilatory support. During the initial weight loss we found no evidence of catabolism. Body solids (weight--TBW) remained unchanged, there was nitrogen retention, and energy intake was sufficient to meet energy expenditure by day 2. ⋯ Blood volume and plasma volume remained unchanged. With the regaining of birth weight there was no increase in body solids despite a high degree of nitrogen retention, but there was a positive fluid balance although no significant increase in any body fluid compartment was found. We conclude that the observed postnatal weight changes reflect changes in interstitial volume.