Clinical trial NCT00515281: Inhaled Nitric Oxide and Neuroprotection in Premature Infants
Official title: Inhaled Nitric Oxide and Neuroprotection in Premature Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Prematurity
Bronchopulmonary Dysplasia
Intraventricular Hemorrhage
Periventricular Leukomalacia
Keywords: prematurity
nitric oxide
bronchopulmonary dysplasia
intraventricular hemorrhage
periventricular leukomalacia
neurodevelopment
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2007-08-13
Enrollment: 273
Sex: ALL
Minimum age (years): 2
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether inhaled nitric oxide improves the neurological outcome for premature infants.

Detailed description: With the advances in modern neonatal intensive care medicine in the last 20 years, survival of extremely preterm infants weighing less than 1500g (\< 3 lbs, 5 oz) has risen markedly. However, with this increased survival has come a marked increase in the number of infants with serious neurodevelopmental disabilities: Premature infants with birth weights less than 1500g who survive to go home are at significant risk for serious neurodevelopmental problems: cognitive and motor delays, blindness, deafness, and cerebral palsy. In a recent randomized, placebo-controlled clinical trial, we assessed whether giving mechanically ventilated preterm infants inhaled nitric oxide gas (iNO) for 1 week after birth decreased the incidence of death and chronic lung disease. An unanticipated outcome of that study (Schreiber et. al. 2003) and a subsequent study of those infants at 2 years of age (Mestan et. al. 2005) was that premature infants treated with inhaled nitric oxide (iNO) have improved neurodevelopmental outcomes and physical growth at 2 years corrected age, compared with placebo-treated infants (Mestan et. al. 2005). INO therapy, therefore, appears to be a new treatment to protect the premature brain during development outside the womb. The overall goal of this application is understand the efficacy of iNO treatment in improving neurodevelopmental outcomes in at-risk premature infants.

Eligibility criteria: Inclusion Criteria:

* Prematurity (birthweight ≤ 1500g, \< 31 weeks gestation)
* Requiring respiratory support
* Admitted to the NICU at the University of Chicago

Exclusion Criteria:

* Severe congenital anomalies
* Genetic syndromes
* Extremely sick preterm infants requiring very high ventilatory pressures (OI ≥ 20)
* Premature infants judged by the physician as nonviable

Primary outcomes:
measure: Neurodevelopment
timeFrame: Two years
measure: Bronchopulmonary Dysplasia (BPD) or Death
timeFrame: 36 weeks of age corrected (BPD) or before discharge (death)
Secondary outcomes:
measure: Death
timeFrame: through discharge (up to 400 days)
measure: Bronchopulmonary Dysplasia
timeFrame: 36 weeks of age corrected
measure: Supplemental Oxygen Use
timeFrame: 40 weeks PMA
measure: BPD or Death in Infants Weighing < 750g
timeFrame: 36 weeks of age corrected (BPD) or before discharge (death)
measure: BPD or Death in Infants Weighing 750-999g
timeFrame: 36 weeks of age corrected (BPD) or before discharge (death)
measure: BPD or Death in Black Infants
timeFrame: 36 weeks of age corrected (BPD) or before discharge (death)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Michael D. Schreiber, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schreiber MD, Gin-Mestan K, Marks JD, Huo D, Lee G, Srisuparp P. Inhaled nitric oxide in premature infants with the respiratory distress syndrome. N Engl J Med. 2003 Nov 27;349(22):2099-107. doi: 10.1056/NEJMoa031154.
citation: Mestan KK, Marks JD, Hecox K, Huo D, Schreiber MD. Neurodevelopmental outcomes of premature infants treated with inhaled nitric oxide. N Engl J Med. 2005 Jul 7;353(1):23-32. doi: 10.1056/NEJMoa043514.