An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants
Status:
Terminated
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
A large patent ductus arteriosus (PDA) is associated with congestive heart failure, pulmonary
hemorrhage, chronic lung disease (CLD), necrotizing enterocolitis (NEC) and intraventricular
bleeding. Indomethacin is the first line of treatment for PDA. Failure of ductal closure with
the first course of indomethacin is reported in 30-40% of infants, with a higher failure rate
in infants weighing < 1000 gm. PDA ligation is associated with early postoperative
hypotension, oxygenation failure and adverse neurodevelopmental outcome in preterm infants.
The use of escalating doses of Indomethacin in the treatment of persistent PDA was found to
be safe and decreased the need for PDA ligation without adverse effects in one observational
study.We hypothesize that the use of an escalated dose of intravenous indomethacin will
result in an increase in the probability of survival without need for surgical ligation of
PDA as compared to a standard dose indomethacin in newborn infants < 29 weeks of gestational
age with persistent PDA.