Intravenous indomethacin therapy in premature infants with patent ductus arteriosus. Causes of death and one-year follow-up.

Fifty-five infants participated in a double-blind study of indomethacin therapy for the closure of patent ductus arteriosus. Seventeen infants died. There was no significant difference in autopsy findings between the groups with respect to pneumonia, disseminated intravascular coagulopathy, necrotizing enterocolitis, sepsis, intraventricular hemorrhage, hydrocephalus, kernicterus, brain softening, and renal damage. For those infants who survived and returned for follow-up at approximately 1 year of age, there was no significant difference between the control (n = 17) and indomethacin (n = 13) groups with respect to physical growth, Bayley scores, respiratory infection, abnormal eye ground, neurological defects, and abnormal EEG. Four in the control group (24%) and three in the indomethacin group (23%) had moderate to severe neurological defects and/or scored less than 80 on the Bayley Mental Development Index or Psychomotor Development Index. It appeared that indomethacin therapy did not have a long-term adverse effect on premature infants.

RCT Entities:   Population Interventions Outcomes