Inhaled Nitric Oxide (INO) In Hypoxic Respiratory Failure

• Status: Withdrawn
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 3, Double-blind, Randomized, Placebo controlled, multicenter study is to confirm the efficacy of inhaled nitric oxide for the management of hypoxic respiratory failure associated with pulmonary hypertension in preterm infants.

Study subjects will be administered either inhaled nitric oxide or placebo to determine if there is a change in oxygenation.

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

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

Preterm infants who:

• Are in-born at < 30 weeks gestational age

• Weigh 500-1250 grams

• Have hypoxic respiratory failure requiring mechanical ventilation with FiO2 > 0.8 to maintain SaO2 ≥ 85% in the first 48 hours after birth after use of exogenous surfactant

• Have minimal parenchymal lung disease by chest X ray

Exclusion Criteria:

Preterm infants who:

• Have ten minute Apgar score < 5

• Have life-threatening anomalies (cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any child who will not receive complete intensive care

• Have bilateral Grade IV Intraventricular Hemorrhage (IVH)

• Are dependent on right to left shunting to maintain the systemic circulation

• Have received prior iNO therapy

• Have had treatment with investigational medications