Double blind randomized controlled trial of 6-day pulse of dexamethasone for very low birth weight infants(VLBW < 1500 grams) who ventilator dependent at 4 weeks of age 1174

Abstract

Between July 1/88 and March 1/92, 20 VLBW infants were found to be ventilator dependent (needed intermittient mandatory ventilation) at 28 days postnatal age. After parental consent, these infants were randomly assigned to receive either a 6-day course of intravenous dexamethasone 0.5 mg/kg/day for 3 days followed by 0.3 mg/kg/day for the final 3 days or to receive an equal volume of saline placebo. 11 infants received dexamethasone and 9 received saline. The groups were similar for use of antenatal steroids, sex, birth weight and the incidences of intrauterine growth retardation, birth depression and hyaline membrane disease. 5/9 infants assigned to the placebo group were born by Caeserean Section compared to 1/11 in the dexamethasone group (p=0.05). Results: There were 3 deaths prior to discharge from hospital, 2 in the dexamethasone group and 1 in the placebo group (p = NS). The remaining results are shown in the table below. Conclusion: Although a trend exists, the number enrolled in this trial was insufficient to detect a statistically significant difference in the number of days ventilated after dexamethasone/placebo treatment. The increased number of days of apneic spells is difficult to explain apart from a trend to earlier weaning from ventilation. The rate of retinopathy of prematurity needs to be carefully examined in larger trials of dexamethasone use in VLBW infants. Dexamethasone Placebo P-Value Median number days ventilated 4.8(2.4-33.0) 18.9(4.6-43.9) [approx]0.10 after treatment(range) Apneic spells(days)^{*} 14 ± 11 2 ± 1 = 0.005 Length of stay(days)^{*} 121 ± 10 154 ± 43 NS 2 year weight(kg)^{*} 11.2 ± 0.7 11.6 ± 0.5 NS 2 year head circumference(cm)* 48.3 ± 0.6 49.2 ± 1.1 NS Corrected MDI^{*} 94 ± 11 93 ± 9 NS Retinopathy of prematurity 64% (7/11) 22% (2/9) = 0.064 Cerebral palsy in survivors 44% (4/9) 25% (2/8) NS Blindness in survivors 11% (1/9) 0% (0/8) NS * Mean ± 1 SD