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

Tufts University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Bronchopulmonary Dysplasia

Treatments: Drug: Placebo Comparator - nitrogen gas; Drug: inhaled nitric oxide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01748045

10487

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 30 to 36 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

3 participants in 2 patient groups, including a placebo group

inhaled Nitric Oxide

Experimental group

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.

Treatment:

Drug: inhaled nitric oxide

Nitrogen Gas

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Comparator - nitrogen gas