Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)
Status:
Terminated
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in
Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume
sites within the NICHD Neonatal Research Network will constitute a pilot sample to evaluate
the feasibility and safety of prolonged IPGE1 administration and determination of optimal
dose. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over
a maximum duration of 72 hours and compared with placebo. Once feasibility and safety of
IPGE1 administered over 72 hours has been demonstrated in the pilot trial, a full scale
randomized controlled trial will be planned.
Phase:
Phase 2
Details
Lead Sponsor:
NICHD Neonatal Research Network
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Center for Research Resources (NCRR)