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

Mallinckrodt451 enrolled

Overview

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.

Multi-center, double blind, placebo-controlled, randomized clinical trial. Infants who meet all enrollment criteria at any point during days 5 to 14 after birth will be randomized to inhaled NO starting at 20 ppm, or matching placebo, by means of a blinded INOvent® delivery device. All infants will receive 24 days of therapy, following a dose reduction schedule. Infants who are extubated before 24 days will continue therapy via nasal continuous positive airway pressure (CPAP) or nasal cannula to complete 24 days' of therapy. The primary outcome measure will be survival without BPD at 36 weeks gestational age using a physiologic assessment of BPD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

451

Conditions

Bronchopulmonary Dysplasia

Interventions

Inhaled Nitric OxideDRUG

Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.

PlaceboDRUG

Nitrogen gas will be administered in the same manner as the experimental drug.

Eligibility

Sex: ALLMin age: 5 DaysMax age: 14 Days

Medical Language ↔ Plain English

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

Locations (33)

Outcomes

Primary Outcomes

Survival Without BPD at 36 Weeks

Time frame: Baseline, 36 weeks PMA

Secondary Outcomes

Days of Airway Pressure Support - Intent-to-treat Population

Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.