Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants

Completed · Phase 3 · Has a placebo group

Conditions studied: Lung Diseases, Bronchopulmonary Dysplasia

In brief

To determine whether or not inhaled nitric oxide (iNO) safely decreases the incidence of chronic lung disease (CLD) in premature infants.

Key facts

Study ID

NCT00006401

Run by

University of Colorado, Denver

People needed

793

Starts

2000-09-01

Expected to finish

2007-10-01

Last updated by the study team

2015-10-06

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Weighing between 500 to 1250 grams at birth
• Gestational age of less than 34 weeks
• Less than 48 hours old
• Respiratory failure on mechanical ventilation
• Absence of structural heart disease (PDA, ASD less than 1 cm, or VSD less than 2 mm are permitted if known prior to study entry)
• Absence of lethal congenital anomaly

You may not qualify if…

• Concurrent participation in another experimental study (observational studies will be allowed with prior approval by the Steering Committee and Data and Safety Monitoring Board)
• Active pulmonary hemorrhage
• Unevaluated pneumothorax
• High frequency jet ventilation
• Expected short duration of ventilation (less than 48 hours from birth)

Where it is running

• St. Joseph's Hospital — Phoenix, Arizona, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Univeristy of Southern California/Good Samaritan Hospital — Los Angeles, California, United States
• Children's Hospital — Denver, Colorado, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• University of Iowa Hospital & Clinics — Iowa City, Iowa, United States
• University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Children's Hospital of Oklahoma — Oklahoma City, Oklahoma, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Magee-Women's Hospital — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Utah Valley Regional Medical Center — Provo, Utah, 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.