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

October 30, 2017 updated by: Mallinckrodt

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

451

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
      • Phoenix, Arizona, United States, 85006
        • Phoenix Children's Hospital
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University School of Medicine
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, United States, 94304
        • Stanford University School of Medicine
      • San Diego, California, United States, 92123
        • Sharp Mary Birch Hospital for Women and Newborns
      • San Diego, California, United States, 92123
        • Rady Children's Hospital of San Diego
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center
    • Florida
      • Orlando, Florida, United States, 32806
        • Winnie Palmer Hospital for Women and Babies
      • Tampa, Florida, United States, 33606
        • University of So Florida College of Medicine
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Children's Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville School of Medicine
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
      • Neptune City, New Jersey, United States, 07754
        • Jersey Shore University Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Hospital
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • Valhalla, New York, United States, 10595
        • Maria Fareri Children's Hospital at Westchester Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Faculty Physicians, Neonatology
    • Ohio
      • Toledo, Ohio, United States, 43608
        • Mercy Children's Hospital
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Saint Francis Children's Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Memorial Hospital
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Sanford Children's Hospital
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53210
        • Wheaton Franciscan Healthcare
      • Wauwatosa, Wisconsin, United States, 53226
        • Children's Corporate Center, Division of Neonatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 days to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 Names:
  • INOmax
Placebo Comparator: Placebo
Nitrogen Placebo
Drug: Placebo
Nitrogen gas will be administered in the same manner as the experimental drug.
Other Names:
  • Nitrogen gas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival Without BPD at 36 Weeks
Time Frame: Baseline, 36 weeks PMA
Baseline, 36 weeks PMA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of Airway Pressure Support - Intent-to-treat Population
Time Frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Length of Birth Hospitalization
Time Frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia
Time Frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason
Time Frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Systemic Use of Postnatal Corticosteroids for Any Medical Reason
Time Frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Number of Days of Oxygen Use
Time Frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Severity of Bronchopulmonary Dysplasia
Time Frame: 36 weeks
Severity of bronchopulmonary dysplasia defined by the fraction of inspired O2 concentration (FiO2) requirement.
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mallinckrodt

Investigators

  • Study Director: James Baldassarre, MD, Mallinckrodt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 1, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Actual)

December 4, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IK-3001-BPD-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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