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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Tufts Medical Center
Sponsor:
Collaborator:
Ikaria
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01748045
First received: November 20, 2012
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Bronchopulmonary Dysplasia
Drug: inhaled nitric oxide
Drug: Placebo Comparator - nitrogen gas
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: The Use of Inhaled Nitric Oxide to Improve Respiratory Outcomes in Late Preterm Infants

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Primary combined endpoint of alive without the need for intubation or mechanical ventilation within the first week of life [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Need for exogenous surfactant [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Total length of hospital stay [ Time Frame: At hospital discharge, anticipate up to 10 weeks ] [ Designated as safety issue: No ]
    participants will be followed for the duration of hospital stay

  • Total duration of supplemental oxygen [ Time Frame: anticipate average 4 weeks ] [ Designated as safety issue: No ]
    participants will be followed for the duration of hospital stay for use of supplemental oxygen

  • Diagnosis of BPD [ Time Frame: At 36 weeks postmenstrual age ] [ Designated as safety issue: No ]
    Diagnosis of BPD by oxygen challenge test at 36 weeks PMA for infants born between 30 and 32 weeks GA. For those born 32 1/7 - 36 weeks, an oxygen challenge test will be performed at 1-2 months of age.

  • Evidence of chronic respiratory morbidity at 12 months CGA [ Time Frame: 12 months corrected gestational age ] [ Designated as safety issue: No ]
    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)

  • Total Duration of Respiratory Support [ Time Frame: anticipate average 4 weeks ] [ Designated as safety issue: No ]
    participants will be followed for the duration of hospital stay for respiratory support


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inhaled Nitric Oxide
iNO 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: 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

  Eligibility

Ages Eligible for Study:   30 Weeks to 36 Weeks
Genders Eligible for Study:   Both
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 > 1LPM, CPAP, or NIPPV for treatment of respiratory failure,
  • Requiring a fraction of inspired oxygen (FIO2) of at least 0.25 to maintain 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 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
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: NCT01748045

Contacts
Contact: Christiane EL Dammann, MD 617-636-4191 cdammann@tuftsmedicalcenter.org

Locations
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Christiane EL Dammann, MD    617-636-4191    cdammann@tuftsmedicalcenter.org   
Contact: Jonathan M Davis, MD    6176364191    jdavis@tuftsmedicalcenter.org   
Principal Investigator: Christiane EL Dammann, MD         
Sponsors and Collaborators
Tufts Medical Center
Ikaria
Investigators
Principal Investigator: Jennifer W Lee, MD, MS Tufts Medical Center
  More Information

No publications provided

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01748045     History of Changes
Other Study ID Numbers: 10487
Study First Received: November 20, 2012
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Tufts Medical Center:
Inhaled Nitric Oxide
Bronchopulmonary Dysplasia
Late Prematurity
Chronic Respiratory Morbidity

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

ClinicalTrials.gov processed this record on October 23, 2014