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