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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00931632
First received: July 1, 2009
Last updated: May 12, 2016
Last verified: May 2016
  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.

Condition Intervention Phase
Bronchopulmonary Dysplasia
Drug: Inhaled Nitric Oxide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • Survival Without BPD at 36 Weeks [ Time Frame: Baseline, 36 weeks PMA ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Days of Airway Pressure Support - Intent-to-treat Population [ Time Frame: during birth hospitalization ] [ Designated as safety issue: No ]
    Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.


Enrollment: 451
Study Start Date: November 2009
Study Completion Date: May 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled Nitric Oxide
Inhaled Nitric Oxide
Drug: 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.
Other Name: INOmax
Placebo Comparator: Placebo
Nitrogen Placebo
Drug: Placebo
Nitrogen gas will be administered in the same manner as the experimental drug.
Other Name: Nitrogen gas

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.
  Eligibility

Ages Eligible for Study:   up to 14 Days   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931632

  Show 33 Study Locations
Sponsors and Collaborators
Mallinckrodt
Investigators
Study Director: James Baldassarre, MD Mallinckrodt
  More Information

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00931632     History of Changes
Other Study ID Numbers: IK-3001-BPD-301 
Study First Received: July 1, 2009
Results First Received: July 16, 2015
Last Updated: May 12, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Mallinckrodt:
Bronchopulmonary Dysplasia, BPD

Additional relevant MeSH terms:
Hyperplasia
Bronchopulmonary Dysplasia
Pathologic Processes
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on August 29, 2016