Inhaled Nitric Oxide Study 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

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.

Key facts

Study ID

NCT00005776

Run by

NICHD Neonatal Research Network

People needed

235

Starts

1995-10-01

Expected to finish

1998-05-01

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…

• Greater than 34 wks gestational age
• One or more of the following diagnoses: primary pulmonary hypertension of the newborn, respiratory distress syndrome, perinatal aspiration syndrome, pneumonia/sepsis, suspected pulmonary hypoplasia
• Oxygenation Index (OI) greater than 15 and less than 25 on 2 arterial blood gases at least 15 min apart
• Indwelling arterial line
• Echocardiography before randomization
• Parental consent

You may not qualify if…

• Congenital diaphragmatic hernia
• Known congenital heart disease
• Decision not to provide full therapy

Where it is running

• Stanford University — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• George Washington University — Washington D.C., District of Columbia, 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
• Texas Children's Hospital — Houston, Texas, United States
• Foothills Hospital — Calgary, Alberta, Canada
• Royal Alexandra Hospital — Edmonton, Alberta, Canada
• British Columbia Children's Hospital — Vancouver, British Columbia, Canada
• Health Sciences Center — Winnipeg, Manitoba, Canada
• McMaster University — Hamilton, Ontario, Canada
• Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada
• Montreal Children's Hospital — Montreal, Quebec, Canada
• Université de Sherbrooke, — Sherbrooke, Quebec, Canada
• Royal University Hospital — Saskatoon, Saskatchewan, Canada

Full record on ClinicalTrials.gov

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