Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure

Stopped early · Phase 3 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT00016523

Run by

NICHD Neonatal Research Network

People needed

420

Starts

2001-01-01

Expected to finish

2006-05-01

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…

• Any infant with a birth weight 401 - 1500 grams and < 34 weeks gestational age with an OI (mean Paw x FiO2 x 100/PaO2) > 10 on two consecutive blood gases at least 30 minutes apart, but no more than 12 hours apart.
• or
• Infants > 1500 grams and < 34 weeks gestational age will be entered in the Larger Preemie Pilot Study if they have an OI greater than or equal to 15 on two consecutive blood gases at least 30 minutes apart, but no more than 12 hours apart.
• Infants requiring assisted ventilation with a diagnosis of RDS/HMD, pneumonia and/or sepsis, aspiration syndrome, idiopathic pulmonary hypertension, or suspected pulmonary hypoplasia associated with PROM and/or oligohydramnios.
• Greater than or equal to 4 hours after one dose of surfactant.
• Less than or equal to 120 hours of age.
• All infants must have an indwelling arterial line.

You may not qualify if…

• Any infant in whom a decision has been made not to provide full treatment (e.g. chromosomal anomalies or severe birth asphyxia).
• Known structural congenital heart disease, except patent ductus arteriosus and atrial-level shunts.
• Infants with any major abnormality involving the respiratory system such as congenital diaphragmatic hernia, tracheoesophageal fistula or cystic fibrosis.
• Any bleeding diathesis considered to be clinically significant or thrombocytopenia with platelet count < 50,000.
• Prior enrollment into a conflicting clinical trial such as the Neonatal Network Surfactant CPAP trial.Inclusion Criteria

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University — Palo Alto, California, United States
• University of California at San Diego — San Diego, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Florida — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Wayne State University — Detroit, Michigan, United States
• University of Rochester — Rochester, New York, United States
• Wake Forest University — Charlotte, North Carolina, United States
• RTI International — Durham, North Carolina, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.