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NCT Number: NCT00931632

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

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

5 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm infants who are:
  • 500 to 1250 grams at birth
  • < 30 weeks gestational age
  • 5 to 14 days of age (inclusive) at the time of entry
  • 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

  • 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
  • Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)
  • Subjects who are dependent on right to left shunting to maintain the systemic circulation
  • Preterm infants who received prior iNO therapy
  • Use of another investigational agent

Treatment and study plan

Inhaled Nitric Oxide

Drug

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

Drug

Nitrogen gas will be administered in the same manner as the experimental drug.

Other names: Nitrogen gas

Primary outcomes

  1. Survival Without BPD at 36 Weeks

    Time frame: Baseline, 36 weeks PMA

Secondary outcomes

  1. 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.

  2. Length of Birth Hospitalization

    Time frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO

  3. 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

  4. 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

  5. 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

  6. Number of Days of Oxygen Use

    Time frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO

  7. Severity of Bronchopulmonary Dysplasia

    Time frame: 36 weeks

    Severity of bronchopulmonary dysplasia defined by the fraction of inspired O2 concentration (FiO2) requirement.

Sponsors and collaborators

Lead sponsor

Mallinckrodt

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Jul 2, 2009
Registry last updated
Dec 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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