Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure
Status:
Withdrawn
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
Summary
This pilot study was a randomized, placebo-controlled, clinical trial to test the safety of
using the intravenous form of Prostaglandin E1 (PGE1) in an inhaled form for treatment of
hypoxemic respiratory failure in term newborns. The study planned to enroll 50 infants
diagnosed with hypoxemic respiratory failure at nine NICHD Neonatal Research Network sites,
and randomly assign them to receive one dose over a 72-hour period of either high
concentration PGE1 (300 ng/kg/min), low concentration PGE1 (150 ng/kg/min), or placebo
(normal saline, the diluent for the drug). In addition to determining the safety, optimal
dose, and duration of the therapy, this pilot trial planned to evaluate the feasibility of
conducting a larger, multi-center randomized, blinded placebo-controlled trial.
Phase:
Phase 2
Details
Lead Sponsor:
NICHD Neonatal Research Network
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)