Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure

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.

Conditions

• Infant, Newborn
• Respiratory Insufficiency
• Pulmonary Hypertension
• Respiratory Distress Syndrome, Newborn
• Streptococcal Infections

Interventions

DRUG

Inhaled Prostaglandin E1

Delivery of one dose of either high dose PGE1 (300 ng/kg/min), low dose PGE1 (150 ng/kg/min), or placebo (normal saline, the diluent for the drug) via nebulizer over a 72-hour period

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Michele C. Walsh, MD MS · Case Western Reserve University, Rainbow Babies and Children's Hospital

• Ronald N. Goldberg, MD · Duke University

• Krisa P. Van Meurs, MD · Stanford University

• Ivan D. Frantz III, MD · Tufts Medical Center

• Waldemar A. Carlo, MD · University of Alabama at Birmingham

• Edward F. Bell, MD · University of Iowa

• Kristi L. Watterberg, MD · University of New Mexico

• Roger G. Faix, MD · University of Utah

• Seetha Shankaran, MD · Wayne State University

• Pablo J. Sanchez, MD · University of Texas, Southwestern Medical Center at Dallas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

7 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-05-31

Primary Completion

2008-09-30

Completion

2008-09-30

Countries

• United States

Study Locations