Early Inhaled Nitric Oxide for Respiratory Failure in Newborns

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Infant, Newborn, Hypertension, Pulmonary, Persistent Fetal Circulation Syndrome, Pneumonia, Aspiration, Respiratory Distress Syndrome, Newborn, Respiratory Insufficiency

In brief

This prospective, randomized controlled trial tested whether initiating iNO therapy earlier would reduce death and reduce the use of extracorporeal membrane oxygenation (ECMO) -- temporary lung bypass -- therapy compared with the standard recommendation threshold. Infants who were born at \>34 weeks' gestation were enrolled when they required assisted ventilation and had an oxygenation index (OI) \>15 and \<25 on any 2 measurements in a 12-hour interval. Infants were randomized to receive either early iNO or to simulated initiation of iNO (control). Infants who had an increase in OI to 25 or more were given iNO as standard therapy. The neurodevelopment of the subjects were evaluated at 18-22 months corrected age.

Key facts

Study ID

NCT00005773

Run by

NICHD Neonatal Research Network

People needed

302

Starts

1998-08-01

Expected to finish

2003-08-01

Last updated by the study team

2017-09-26

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants born at >34 weeks gestational age
• Require assisted ventilation for hypoxic respiratory failure
• Have a diagnosis of primary persistent pulmonary hypertension (PPHN), respiratory distress syndrome, perinatal aspiration syndrome, pneumonia/sepsis, or suspected pulmonary hypoplasia
• Have an oxygenation index >15 and <25 based on 2 arterial blood gases taken at least 15 minutes apart or an Fi02 >80%
• In-dwelling arterial line
• Parental consent

You may not qualify if…

• Known structural congenital heart disease, except patent ductus arteriosus and atrial level shunts
• Congenital diaphragmatic hernia
• Use of high frequency jet ventilation at the time of randomization
• Prior exposure to inhaled nitric oxide therapy

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• St. Joseph's Hospital — Phoenix, Arizona, United States
• Stanford University — Palo Alto, California, United States
• San Diego Children's Hospital — San Diego, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Wayne State University — Detroit, Michigan, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Tennessee — Memphis, Tennessee, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• University of Washington School of Medicine — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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