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

Mallinckrodt

Status and phase: Completed; Phase 3

Conditions: Bronchopulmonary Dysplasia

Treatments: Drug: Inhaled Nitric Oxide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00931632

IK-3001-BPD-301

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 451 patients

Sex: All

Ages: 5 to 14 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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451 participants in 2 patient groups, including a placebo group

Inhaled Nitric Oxide

Experimental group

Description:

Inhaled Nitric Oxide

Treatment:

Drug: Inhaled Nitric Oxide

Placebo

Placebo Comparator group

Description:

Nitrogen Placebo

Treatment:

Drug: Placebo