Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure

• Status: Withdrawn
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Alprostadil

Criteria

Inclusion Criteria:

• Infants born at 34 0/7ths weeks gestational age or greater (by best obstetrical estimate) and at a postnatal age no greater than 7 days (168 hours)

• Infants diagnosed with hypoxemic respiratory failure (HRF), including perinatal aspiration syndrome (meconium, blood, or amniotic fluid), pneumonia/ sepsis, respiratory distress syndrome, or idiopathic respiratory failure

• Infants who will receive assisted ventilation for HRF

• Infants with an oxygenation index (MAP x FiO2 x 100/PaO2)(OI) of 15-25 on two arterial gases taken between 15 minutes and 12 hours apart

• An indwelling arterial line

• Infants whose parents/legal guardians have provided consent for enrollment

Exclusion Criteria:

• Any infant in whom a decision has been made not to provide full treatment

• Known structural congenital heart disease, except patent ductus arteriosus and atrial/ventricular level shunts

• Congenital diaphragmatic hernia

• Preterm neonates less than 34 weeks

• Thrombocytopenia (platelet count < 80,000/μl) unresponsive to platelet transfusion

• Infants receiving hypothermia for hypoxic ischemic encephalopathy

• Previous treatment with inhaled nitric oxide

• Infants already enrolled in a conflicting and/or Investigational New Drug (IND) clinical trial

• Infants whose parents/legal guardians refuse consent