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To determine whether early (less than or equal to 12 hours) postnatal dexamethasone therapy would facilitate removal of the endotracheal tube and improve outcome in premature infants with severe respiratory distress syndrome, we conducted a double-blind, controlled study of 57 infants whose birth weights were less than 2000 gm. The placebo (n = 29) and treated (n = 28) groups were comparable in birth weight (mean +/- SD: 1273 +/- 323 vs 1318 +/- 359 gm), gestational age (30.1 +/- 2.1 vs 30.8 +/- 2.7 weeks), postnatal age (8.7 +/- 3.1 vs 8.5 +/- 3.1 hours), and pulmonary function at the start of the study. The dose of dexamethasone was 1.0 mg/kg/day for 3 days and then was progressively decreased for 12 days. Infants in the dexamethasone group had significantly higher pulmonary compliance, tidal volume, and minute ventilation, and required lower mean airway pressure for ventilation than infants in the placebo group. The endotracheal tube was successfully removed from more infants in the dexamethasone group (16/28 vs 8/29; p less than 0.025). Nineteen infants (65%) in the placebo group and 11 (39%) in the dexamethasone group (p less than 0.05) had lung injuries. Dexamethasone therapy was associated with a temporary increase in blood pressure and plasma glucose concentration and a delay in somatic growth. We conclude that early postnatal dexamethasone therapy improves pulmonary status, facilitates removal of the endotracheal tube, and minimizes lung injuries in premature infants with severe respiratory distress syndrome.

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To determine energy use and growth of infants with bronchopulmonary dysplasia (BPD), we studied metabolic rate and energy balance in five infants with stage III-IV BPD (birth weight 1309 +/- 530 gm, gestational age 32 +/- 3 weeks, postnatal age 59.8 +/- 14.2 days) and in five control infants (birth weight 1540 +/- 213 gm, gestational age 33 +/- 2 weeks, postnatal age 42.0 +/- 4.2 days). Infants with BPD had significantly lower energy intake but higher energy expenditure than did control infants. Weight gain and energy cost of growth were significantly less in BPD infants than in control infants, as were urine output and output/intake ratio. We conclude that infants with BPD (1) absorbed caloric intake as well as did normal control infants, (2) had low energy intake and high energy expenditure, resulting in poor weight gain, and (3) had low energy cost of growth, suggesting an alteration in composition of tissue gain, with relatively high water content.

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Pulmonary edema has been demonstrated in the early stages of respiratory distress syndrome in premature infants. To evaluate whether early furosemide therapy (0 to 8 hours after birth) would affect the electrolyte balance, pulmonary status, and outcome, 57 infants (less than or equal to 2000 gm) with respiratory distress syndrome who required mechanical ventilation shortly after birth were randomized into two groups: 29 given furosemide (1 mg/kg/day intravenously for three doses) and 27 control. The clinical, biochemical, and laboratory characteristics of the groups were comparable before entry into the study. Administration of furosemide significantly enhanced the urinary excretion of Na and Cl at 0 to 24, 24 to 48 and 48 to 72 hours and of Ca at 24 to 48 and 48 to 72 hours after drug administration. There was no significant difference between the groups in urinary excretion of K and in serum Na, Cl, K, and Ca values. A spontaneous increase in urine output occurred in the control group at 48 to 72 hours after the initiation of the study (mean +/- SD 7.0 +/- 3.5 hours postnatal age), along with a decrease in mean airway pressure for mechanical ventilation. The use of furosemide (7.3 +/- 3.5 hours postnatal age) enhanced urine output at 24 to 48 and 48 to 72 hours after medication, resulting in further decrease in mean airway pressure and facilitating extubation. There was, however, no significant difference between the groups with respect to incidence of patent ductus arteriosus, morbidity from bronchopulmonary dysplasia, and mortality.

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To determine if furosemide would prevent the renal side effects of indomethacin therapy in premature infants with patent ductus arteriosus, 19 premature infants were randomized into two groups: nine received indomethacin alone, and ten received indomethacin followed immediately by furosemide. There was no significant difference between the groups in birth weight, gestational age, postnatal age, and in cardiopulmonary or renal status at the time of study. Infants who received indomethacin and furosemide had significantly higher urine output (P less than 0.05), higher FENa and FECl (P less than 0.01), and higher glomerular filtration rate (P less than 0.05) than those of infants who received indomethacin alone. Seven infants in each group responded to indomethacin therapy with disappearance of PDA murmur and improvement of cardiovascular status. The results of this study suggest that furosemide may prevent the renal side effects of indomethacin therapy and yet not affect the efficacy of indomethacin in the closure of a PDA.

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A loading dose of theophylline produces significant metabolic changes, including increase of plasma glucose concentration and an early rise in serum insulin in some infants. The chronic effects of theophylline on plasma glucose, serum insulin, and glucagon are not known at this time. The potential for development of metabolic derangements must be kept in mind when theophylline is used for protracted periods in premature infants.

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A double-blind controlled trial of intravenous indomethacin therapy was performed using a group of 55 premature infants (27 placebo, 28 indomethacin) with a significant persistent ductus arteriosus. Indomethacin administration at a mean postnatal age of 8.9 days was followed by a significant effect on PDA in 89%; 75% of successes were attributable to indomethacin and 25% to spontaneous effects, an improvement by indomethacin of 86% in infants not undergoing spontaneous improvement. The short-term side effects of indomethacin were transient; urinary output and serum sodium concentration decreased and serum potassium concentration increased. Indomethacin administration was associated with a decreased need for assisted ventilation and a decreased need for surgical closure of PDA. There was no significant difference between the placebo and indomethacin groups in mortality and bronchopulmonary dysplasia morbidity. The infants who developed BPD had higher RDS scores and lower PO2 values, requiring higher FIO2s within four hours of birth than those who did not develop BPD, indicating a more severe underlying pulmonary disability present birth.

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Fifteen studies were performed in ten premature infants whose birth weight (mean +/- SD) was 1,444 +/- 250 gm, gestational age 32.7 +/- 1.0 weeks, and postnatal age 10.7 +/- 3.3 days. Each study consisted of three hours simultaneous measurement of insensible water loss and oxygen consumption under two conditions for the same infant: (1) inside a single-walled incubator and (2) inside a double-walled incubator. The double-walled incubator provided significantly (P < 0.001) higher operative temperature and incubator wall temperature than did the single-walled incubator. Infants inside the double-walled incubator had significantly lower (P < 0.01) IWL (30% reduction) and lower (P < 0.05) VO2 (17% reduction) than inside the single-walled incubator--a net caloric saving of 11.8 kcal/kg/day. This saving of energy expenditure may be important in affecting the growth and outcome of the low-birth-weight infants.

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We studied the pharmacokinetics of indomethacin (0.3 mg/kg) given intravenously in 17 premature infants to promote closure of persistent ductus arteriosus. The decay of indomethacin generally showed an initial rapid distribution (alpha) phase followed by a slower elimination (beta) phase. The mean half-life of elimination (20.7 +/- 8 hours) was three times longer, and the mean clearance rate (13 +/0 9.5 ml/kg/hour) was seven times less than that reported in adults. The indomethacin clearance rate was linearly correlated with postnatal age (r = 0.71, P < 0.01). There was strong evidence of later re-entry of indomethacin into the plasma, suggesting that enterohepatic recirculation may be common in premature infants and may contribute to the relatively long half-life of elimination. Our data do not clarify the question of target concentration or minimal exposure time above which permanent closure may occur, but the group of infants who had permanent PDA closure after only one dose (8/17) had a significantly higher plasma indomethacin concentration time integral than the group (9/17) who needed more than one dose (P < 0.01). A 24-hour dosage interval was often sufficient when an iv indomethacin bolus of 0.3 mg/kg was used but, below the age of nonresponsiveness to indomethacin, a shorter interval may be preferable as postnatal age increases.

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To evaluate the efficacy of glucocorticoids in the treatment of infants with meconium aspiration syndrome, a double-blind study using hydrocortisone or a lactose placebo was undertaken. Thirty-five infants were included in the study. No significant differences in arterial Po2, Pco2, pH, A-aDo2 gradients, in requirement for assisted ventilation, or in survival were domonstrated between the groups. In control infants, a significant decrease (p less than 0.01) in respiratory distress score was found at 48 to 72 hours of age; in treated infants, it was seen only after 72 hours. The infants in the treated group took a significantly longer (p less than 0.01) period of time to wean to room air than those in the control group (68.9 +/- 9.6 hours vs 36.6 +/- 6.9 hours). On the basis of these observations, hydrocortisone is not recommended for treatment of MAS.

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