Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)