Brief Title
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
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
Brief Summary
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.
Detailed 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Survival Without BPD at 36 Weeks
Secondary Outcome
Days of Airway Pressure Support - Intent-to-treat Population
Condition
Bronchopulmonary Dysplasia
Intervention
Inhaled Nitric Oxide
Study Arms / Comparison Groups
Inhaled Nitric Oxide
Description: Inhaled Nitric Oxide
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
451
Start Date
November 2009
Completion Date
May 2014
Primary Completion Date
May 2013
Eligibility Criteria
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
Gender
All
Ages
5 Days - 14 Days
Accepts Healthy Volunteers
No
Contacts
James Baldassarre, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00931632
Organization ID
IK-3001-BPD-301
Responsible Party
Sponsor
Study Sponsor
Mallinckrodt
Study Sponsor
James Baldassarre, MD, Study Director, Mallinckrodt
Verification Date
October 2017