Clinical trial NCT01748045: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Bronchopulmonary Dysplasia
Keywords: Inhaled Nitric Oxide
Bronchopulmonary Dysplasia
Late Prematurity
Chronic Respiratory Morbidity
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2012-12-12
Enrollment: 3
Sex: ALL
Minimum age (years): 30
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life
timeFrame: 7 days
Secondary outcomes:
measure: Number of Participants Who Had the Need for Exogenous Surfactant
timeFrame: 7 days
measure: Total Length of Hospital Stay
timeFrame: From hospital admission through discharge
measure: Total Duration of Supplemental Oxygen
timeFrame: From Hospital Admission through discharge
measure: Diagnosis of Bronchopulmonary Dysplasia (BPD)
timeFrame: At 36 weeks postmenstrual age or 1-2month of age
measure: Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA)
timeFrame: 12 months corrected gestational age
measure: Total Duration of Respiratory Support
timeFrame: From hospital admission through discharge
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Jennifer W Lee, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: