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

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Bronchopulmonary dysplasia
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Brief Title

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

Official Title

The Use of Inhaled Nitric Oxide to Improve Respiratory Outcomes in Late Preterm Infants

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.

Study Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life

Secondary Outcome

 Number of Participants Who Had the Need for Exogenous Surfactant

Condition

Bronchopulmonary Dysplasia

Intervention

inhaled nitric oxide

Study Arms / Comparison Groups

 inhaled Nitric Oxide
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

3

Start Date

March 2013

Completion Date

July 2014

Primary Completion Date

July 2014

Eligibility 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.

Gender

All

Ages

30 Weeks - 36 Weeks

Accepts Healthy Volunteers

No

Contacts

Jennifer W Lee, MD, MS, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01748045

Organization ID

10487

Responsible Party

Sponsor

Study Sponsor

Tufts Medical Center

Collaborators

 Mallinckrodt

Study Sponsor

Jennifer W Lee, MD, MS, Principal Investigator, Tufts Medical Center

Verification Date

June 2017