Pediatric Trials

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Mallinckrodt

Intervention(s):

  • Drug: Inhaled Nitric Oxide
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

N/A - 14 Days

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
M. Bethany Ball
6507258342
Recruiting