Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
Trial ID or NCT#
NCT00931632
Status
RECRUITING
Purpose
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.
Official Title
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Requiring Mechanical Ventilation or Positive Pressure Support on Days 5-14 After Birth
Eligibility Criteria
Ages Eligible for Study: 5 Days to 14 Days
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Contact us to find out if this trial is right for you.
Contact
M. Bethany Ball
6507258342
View on ClinicalTrials.gov
