Pulmonary function and outcomes in infants randomized to a rescue course of antenatal steroids.

BACKGROUND/OBJECTIVE: Our objective was to obtain follow-up pulmonary function testing and assessment of clinical respiratory outcomes, at 1-2 years, in preterm infants whose mothers were randomized to a single rescue course of antenatal steroids (AS) versus placebo. METHODS: Follow-up of a randomized, double-blinded trial. In the original trial pregnant women ≥14 days after initial course of AS were randomized to rescue AS or placebo. Pulmonary function testing and a standardized respiratory questionnaire were obtained at 1-2 years of corrected age. Respiratory compliance (Crs) was measured with the single-breath occlusion and functional residual capacity (FRC) with the nitrogen washout method. Analysis was by intention-to-treat. RESULTS: A total of 96 (87%) of available survivors were administered a respiratory questionnaire. Seventy-seven percent of available patients had pulmonary function testing performed. There was no significant difference between groups in incidence of wheezing, asthma, respiratory syncytial virus infection, respiratory readmissions, use of bronchodilators or other medications, or in measurements of pulmonary function. There was also no significant difference in corrected age at study, race, gender, or length at the time of pulmonary function testing. Infants in the rescue group had a comparable mean FRC (249.4 mL vs 246.2 mL; adjusted 95%CI for difference -15.45, 38.20; P = 0.37) versus placebo. There were no differences in tidal volume or Crs. CONCLUSION: A rescue course of AS significantly increases Crs within 72 h of age and decreases oxygen need in newborn infants, without an adverse impact on pulmonary function or clinical respiratory outcomes at 1-2 years of age [NCT00669383].

Respiratory compliance in preterm infants after a single rescue course of antenatal steroids: a randomized controlled trial.

OBJECTIVE: To compare respiratory compliance and functional residual capacity in infants randomized to a rescue course of antenatal steroids vs placebo. STUDY DESIGN: Randomized, double-blinded trial. Pregnant women > or =14 days after initial antenatal steroids were randomized to rescue antenatal steroids or placebo. The primary outcomes were measurements of respiratory compliance and functional residual capacity. This study is registered with clinicaltrials.gov (NCT00669383). RESULTS: Forty-four mothers (56 infants) received rescue antenatal steroids and 41 mothers (57 infants) received placebo. There was no significant difference in birthweight, or head circumference. Infants in the rescue group had an increased respiratory compliance (1.21 vs 1.01 mL/cm H(2)O/kg; adjusted 95% confidence interval, 0.01-0.49; P = .0433) compared with placebo. 13% in the rescue vs 29% in the placebo group required > or =30% oxygen (P < .05). Patients delivered at < or =34 weeks had greater pulmonary benefits. CONCLUSION: Infants randomized to rescue antenatal steroids have a significantly increased respiratory compliance compared with placebo.

Randomized, double-blinded trial of low-dose dexamethasone: II. Functional residual capacity and pulmonary outcome in very low birth weight infants at risk for bronchopulmonary dysplasia.

We previously reported on a 7-day course of dexamethasone starting at 0.5 mg/kg/day in intubated very low birth weight (VLBW) infants, 7-14 days of age, with increased dynamic pulmonary compliance and decreased bronchopulmonary dysplasia (BPD). The effect of low-dose dexamethasone on functional residual capacity (FRC) in VLBW infants is unknown. The objective of this study was to compare the effect of two regimens of moderately early dexamethasone on FRC and passive respiratory compliance (Crs) in VLBW infants at risk for BPD. Sixty-two intubated VLBW infants were randomized (double-blinded) at 7-21 days of age; 29 patients (mean birth weight, 839 g) received "high" dose dexamethasone (0.5 mg/kg/day for 3 days, 0.25 mg/kg/day for 3 days, and 0.1 mg/kg/day on day 7, total dose of 2.35 mg/kg), and 33 infants (mean birth weight, 830 g) received "low-dose" dexamethasone (0.2 mg/kg/day for 3 days and 0.1 mg/kg/day for 4 days, total dose of 1 mg/kg). FRC and Crs were measured with the nitrogen washout technique and single breath occlusion technique, before and on days 2, 5, and 7 of therapy. Clinical outcome and early neurodevelopmental follow-up were evaluated. FRC significantly increased in the high-dose (19.3 ml/kg at baseline to 34 ml/kg on day 7; P < 0.001) and low-dose (18.1 ml/kg at baseline to 30.3 ml/kg on day 7; P < 0.001) dexamethasone groups when compared to baseline. There was a significant increase in Crs and a decrease in FiO2 within each group. The improvements in FRC and Crs were comparable between groups, and specific compliances (Crs/FRC) were not different. There were no significant differences in other clinical outcome parameters, including BPD and neurodevelopmental outcome. In conclusion, there are significant increases in FRC during a 7-day course of moderately early dexamethasone in VLBW infants. The lower total dose (1 mg/kg) appears as effective as the higher total dose of dexamethasone (2.35 mg/kg) in increasing FRC. Comparable significant increases in Crs were observed in both groups of infants. Additional long-term follow-up is underway.

The effect of a single remote course versus weekly courses of antenatal corticosteroids on functional residual capacity in preterm infants: a randomized trial.

OBJECTIVE: There are no randomized data on the effect of repeat courses of corticosteroids during pregnancy on newborn pulmonary function. Our objective was to compare the effect of a single remote course of antenatal steroids (AS) with weekly courses of AS on functional residual capacity (FRC) and respiratory compliance in preterm infants. STUDY DESIGN/METHODS: Pregnant women 25 to 33 weeks' gestation, who remained undelivered 1 week after their first course of antenatal corticosteroids (two 12-mg doses of betamethasone) were randomized to weekly courses of corticosteroids versus weekly placebo until delivery or 34 weeks' gestation. FRC was measured with the nitrogen washout technique and respiratory compliance with the single breath occlusion technique within 48 hours of life. RESULTS: Thirty-seven infants (mean gestational age at delivery approximately 32.5 weeks) were studied. Maternal and infant demographics were similar. There was no significant difference in FRC (28.5 vs 27.5 mL/kg) or respiratory compliance between the infants who received a single remote course of antenatal corticosteroids and those who received weekly courses of corticosteroids until delivery. There was no significant difference in admission head circumference or birth weights between the groups. CONCLUSIONS: Our results demonstrate that weekly repetitive courses of AS do not significantly increase FRC or respiratory compliance in preterm infants when compared with a single remote course of steroids given at a mean gestational age of 29 weeks.