Inhaled Nitric Oxide and Neuroprotection in Premature Infants
This trial is active, not recruiting.
|Conditions||prematurity, bronchopulmonary dysplasia, intraventricular hemorrhage, periventricular leukomalacia|
|Treatments||inhaled nitric oxide, oxygen|
|Phase||phase 2/phase 3|
|Sponsor||University of Chicago|
|Start date||May 2008|
|End date||January 2016|
|Trial size||484 participants|
|Trial identifier||NCT00515281, 15405A|
The purpose of this study is to determine whether inhaled nitric oxide improves the neurological outcome for premature infants.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: Two years
time frame: 36 weeks of age corrected
Severe IVH / PVL
time frame: 40 weeks of age corrected
Male or female participants up to 72 hours old.
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
|Official title||Inhaled Nitric Oxide and Neuroprotection in Premature Infants|
|Principal investigator||Michael D. Schreiber, M.D.|
|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.|
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