EFFECT OF PULSE DEXAMETHASONE THERAPY ON THE INCIDENCE AND SEVERITY OF CHRONIC LUNG-DISEASE IN THE VERY-LOW-BIRTH-WEIGHT INFANT

We conducted a prospective, randomized, double-blind trial to assess t he efficacy and safety of pulse doses of dexamethasone on survival wit hout supplemental oxygen in very low birth weight infants at high risk of having chronic lung disease, Seventy-eight infants with birth weig hts less than or equal to 1500 gm who were ventilator dependent at 7 d ays of postnatal age were randomly assigned to receive pulse doses of dexamethasone, 0.5 mg/kg per day, divided twice daily (n = 39), or an equivalent volume of saline solution placebo (n = 39), for 3 days at 1 0-day intervals until they no longer required supplemental oxygen or a ssisted ventilation, or reached 36 weeks of postmenstrual age. At stud y entry, the groups did not differ by birth weight, gestational age, o r severity of lung disease. At 36 weeks of postmenstrual age, there wa s both a significant increase in survival rates without oxygen supplem entation (p = 0.03) and a significant decrease in the incidence of chr onic lung disease (p = 0.047) in the group that received pulse therapy , supplemental oxygen requirements were less throughout the study peri od in the group that received repeated pulse doses of dexamethasone (p = 0.013), The total numbers of deaths and the durations of supplement al oxygen, ventilator support, and hospital stay did not differ betwee n groups, Recorded side effects in the pulse therapy group were minima l and included an increase in the use of insulin therapy for hyperglyc emia (p < 0.05), We conclude that in this population of very low birth weight infants, treatment with pulse doses of dexamethasone resulted in improvement in pulmonary outcome without clinically significant sid e effects.