Inhaled Nitric Oxide Study for Respiratory Failure in Newborns

Summary

Respiratory failure in term newborns is associated with increased rates of death and long-term neurodevelopmental problems. This large international multicenter trial randomized newborns who had failed to respond to intensive care, including high levels of ventilator support, to receive either inhaled nitric oxide (iNO) or 100 percent oxygen to test whether iNO would decrease their risk of dying or requiring temporary lung bypass. Infants were followed during their initial hospitalization; their outcome was assessed at 18 to 24 mos of age.

Conditions

• Infant, Newborn
• Hypertension, Pulmonary
• Persistent Fetal Circulation Syndrome
• Pneumonia, Aspiration
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Interventions

DRUG

Inhaled nitric oxide

Inhaled Nitric oxide at a concentration of 20 ppm

DRUG

Placebo

100% Oxygen

Sponsors & Collaborators

• Medical Research Council of Canada

  collaborator OTHER

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Richard A. Ehrenkranz, MD · Yale University

• David K. Stevenson, MD · Stanford University

• Raymond Bain, PhD · George Washington University

• James A. Lemons, MD · Indiana University

• Seetha Shankaran, MD · Wayne State University

• Lu-Ann Papile, MD · University of New Mexico

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

• Avroy A. Fanaroff, MD · Case Western Reserve University, Rainbow Babies and Children's Hospital

• William William Oh, MD · Brown University, Women & Infants Hospital of Rhode Island

• Sheldon B. Korones, MD · University of Tennessee

• Mary Wearden, MD · Baylor College of Medicine

• N. Singhal, MD · Foothills Hospital, Calgary, Canada

• Neil N. Finer, MD · Royal Alexandra Hospital

• A. Solimano, MD · British Columbia Children's Hospital

• C. Fajardo, MD · Health Sciences Center, Winnipeg, Manitoba

• H. Kirpalani, MD · McMaster University

• R. Walker, MD · Children's Hospital of Eastern Ontario

• A. Johnston, MD · Montreal Children's Hospital of the MUHC

• P. Blanchard, MD · Université de Sherbrooke, Sherbrooke, Quebec

• K. Sankarhan, MD · Royal University Hospital, Saskatoon, Saskatchewan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

14 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1995-10-31

Primary Completion

1996-05-31

Completion

1998-05-31

Countries

• United States
• Canada

Study Locations