This trial is active, not recruiting.

Condition bronchopulmonary dysplasia
Treatments inhaled nitric oxide, placebo
Phase phase 3
Sponsor INO Therapeutics
Start date November 2009
End date May 2013
Trial size 450 participants
Trial identifier NCT00931632, IK-3001-BPD-301


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Inhaled Nitric Oxide
inhaled nitric oxide
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.
(Placebo Comparator)
Nitrogen Placebo
Nitrogen gas will be administered in the same manner as the experimental drug.

Primary Outcomes

Survival without BPD at 36 weeks
time frame: Baseline, 36 weeks PMA

Secondary Outcomes

Vital Signs
time frame: Study duration
Need for respiratory support
time frame: Study duration up to discharge
Adverse Events
time frame: During study drug administration only
Incidence of methemoglobinemia
time frame: Baseline, 24, 48 and 72 hours

Eligibility Criteria

Male or female participants up to 14 days old.

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

Additional Information

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
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 GA using a physiologic assessment of BPD.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by INO Therapeutics.