Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure

Summary

This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Respiratory Distress Syndrome (RDS)
• Sepsis
• Pneumonia
• Hypertension, Pulmonary

Interventions

DRUG

Inhaled nitric oxide

Started at 5 ppm and could be increased to 10 ppm

DRUG

Placebo

Started at 5 ppm and could be increased to 10 ppm

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Krisa P. Van Meurs, MD · Stanford University

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

• Abbot R. Laptook, MD · Brown University, Women & Infants Hospital of Rhode Island

• Edward F. Donovan, MD · Children's Hospital Medical Center, Cincinnati

• James A. Lemons, MD · Indiana University

• Shahnaz Duara, MD · University of Miami

• Charles R. Rosenfeld, MD · University of Texas, Southwestern Medical Center at Dallas

• Jon E. Tyson, MD MPH · The University of Texas Health Science Center, Houston

• Seetha Shankaran, MD · Wayne State University

• Richard A. Ehrenkranz, MD · Yale University

• T. Michael O'Shea, MD MPH · Wake Forest University

• Neil N. Finer, MD · University of California, San Diego

• Dale L. Phelps, MD · University of Rochester

• Mark L. Hudak, MD · University of Florida

• Robin H. Steinhorn, MD · Northwestern University

• G. Ganesh Konduri, MD · Medical College of Wisconsin, Milwaukee

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Max Age

120 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-01-31

Primary Completion

2003-09-30

Completion

2006-05-31

Countries

• United States

Study Locations