Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.

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

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• Preterm infants who are:

1. 500 to 1250 grams at birth

2. < 30 weeks gestational age

3. 5 to 14 days of age (inclusive) at the time of entry

4. Requiring mechanical ventilation or for those infants ≤ 800 grams, positive pressure support (including CPAP) for respiratory insufficiency on days 5 to 14 days of age (inclusive)

Exclusion Criteria:

1. Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject who will not receive complete intensive care

2. Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)

3. Subjects who are dependent on right to left shunting to maintain the systemic circulation

4. Preterm infants who received prior iNO therapy

5. Use of another investigational agent