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Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants

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ClinicalTrials.gov Identifier: NCT01748045
Recruitment Status : Terminated (Enrollenment has been suspended due to poor enrollment)
First Posted : December 12, 2012
Results First Posted : July 19, 2017
Last Update Posted : July 19, 2017
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Tufts Medical Center

Study Description
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Brief Summary:
The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36 weeks and who require breathing support with high flow nasal cannula, nasal continuous positive airway pressure, or nasal intermittent positive pressure will be randomized to receive either inhaled nitric oxide or placebo. The dose will then be decreased per protocol until all respiratory support has been discontinued. Infants will be followed to evaluate safety and efficacy of non-invasive iNO delivery, up to 12 months corrected gestational age.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Drug: inhaled nitric oxide Drug: Placebo Comparator - nitrogen gas Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Use of Inhaled Nitric Oxide to Improve Respiratory Outcomes in Late Preterm Infants
Study Start Date : March 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: inhaled Nitric Oxide
iNO to start at 20 parts per million (ppm) for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
 Drug: inhaled nitric oxide
Other Name: iNO, INOmax
Placebo Comparator: Nitrogen Gas
Placebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
 Drug: Placebo Comparator - nitrogen gas


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Number of Participants Who Had the Need for Exogenous Surfactant [ Time Frame: 7 days ]
  2. Total Length of Hospital Stay [ Time Frame: From hospital admission through discharge ]
    participants who were followed for the duration of hospital stay

  3. Total Duration of Supplemental Oxygen [ Time Frame: From Hospital Admission through discharge ]
    Participants were followed for the duration of hospital stay for use of supplemental oxygen

  4. Diagnosis of Bronchopulmonary Dysplasia (BPD) [ Time Frame: At 36 weeks postmenstrual age or 1-2month of age ]
    Diagnosis of BPD by oxygen challenge test at 36 weeks post menstrual age (PMA) for infants born between 30 and 32 weeks gestational age (GA). For those born 32 1/7 - 36 weeks, an oxygen challenge test was performed at 1-2 months of age.

  5. Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA) [ Time Frame: 12 months corrected gestational age ]
    defined by a validated system of parental diaries and pulmonary questionnaires, as well as review of medical records (medical visits, respiratory medication use, emergency room visits, and hospital re-admissions)

  6. Total Duration of Respiratory Support [ Time Frame: From hospital admission through discharge ]
    participants were followed for the duration of hospital stay for respiratory support


Eligibility Criteria
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Ages Eligible for Study:   30 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • <48 hours of age,
  • 30 - 36 weeks gestational age at birth based on best estimate using obstetrical sonography (first or second trimester), solid dating criteria, or Ballard examination,
  • Birth weight of ≥ 1,000 g,
  • 5 minute Apgar score ≥5,
  • Requiring nasal cannula O2 > 1 liter per minute (LPM), continuous positive pressure (CPAP), or non invasive positive pressure ventilation (NIPPV) for treatment of respiratory failure,
  • Requiring a fraction of inspired oxygen (FIO2) of at least 0.25 to maintain arterial oxygen saturation (SaO2) 88-94%,
  • Parent or guardian has signed informed consent and agrees to all study- related procedures, including those required after hospital discharge.

Exclusion Criteria:

  • Major congenital anomaly
  • Intubation and surfactant in the delivery room or prior to enrollment in the Neonatal Intensive Care Unit (NICU). Excludes intubation for suctioning.
  • Known congenital infection (bacterial, viral),
  • Perinatal asphyxia (5 minute Apgar <5, umbilical artery pH < 7.0 or evidence of neonatal encephalopathy),
  • Mother and/or infant is enrolled in another clinical trial (excluding observational) or has received an investigational drug,
  • Has undergone or is anticipated to require a major surgical procedure within the first 48 h of life,
  • Any condition which could preclude receiving study drug or performing any study-related procedures,
  • Use of postnatal corticosteroids,
  • Parent or guardian is unable or unwilling to complete study procedures after hospital discharge.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748045


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Mallinckrodt
Investigators
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Principal Investigator: Jennifer W Lee, MD, MS Tufts Medical Center
More Information
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01748045    
Other Study ID Numbers: 10487
First Posted: December 12, 2012    Key Record Dates
Results First Posted: July 19, 2017
Last Update Posted: July 19, 2017
Last Verified: June 2017
Keywords provided by Tufts Medical Center:
Inhaled Nitric Oxide
Bronchopulmonary Dysplasia
Late Prematurity
Chronic Respiratory Morbidity
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Lung Injury
Lung 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