Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)

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.

Conditions

• Prematurity
• Respiratory Insufficiency
• Pulmonary Hypertension
• Respiratory Distress Syndrome, Newborn

Interventions

DRUG

Aerosolized Normal Saline

Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 \[150\], IPGE1 \[300\], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. Placebo will be administered over a maximum duration of 72 hours.

DRUG

Inhaled PGE1

Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 \[150\], IPGE1 \[300\], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours to determine the optimal dose and duration of therapy.

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

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

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Beena Sood, MD · Wayne State University

• Martin Keszler, MD · Brown University, Women & Infants Hospital of Rhode Island

• C. Michael Cotten, MD · Duke University

• Abhik Das, PhD · RTI International

• Krisa P Van Meurs, MD · Stanford University

• Namasivayam Ambalavanan, MD · University of Alabama at Birmingham

• Jonathan M Klein, MD · University of Iowa

• Robin Ohls, MD · University of New Mexico

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

• Satyan Lakshminrusimha, MD · University of Rochester

• Uday Devaskar, MD · University of California, Los Angeles

• Leif Nelin, MD · Research Institute at Nationwide Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Max Age

7 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2012-05-31

Completion

2012-06-30

Countries

• United States

Study Locations