Study of Inhaled Nitric Oxide and Respiratory Outcomes in Late Preterm Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Bronchitis |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/7/2015 |
| Start Date: | March 2013 |
| Contact: | Christiane EL Dammann, MD |
| Email: | cdammann@tuftsmedicalcenter.org |
| Phone: | 617-636-4191 |
The Use of Inhaled Nitric Oxide to Improve Respiratory Outcomes in Late Preterm Infants
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.
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.
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.
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