Inhaled Nitric Oxide and Neuroprotection in Premature Infants
Overview
- Phase
- Phase 2
- Intervention
- inhaled nitric oxide
- Conditions
- Prematurity
- Sponsor
- University of Chicago
- Enrollment
- 273
- Locations
- 1
- Primary Endpoint
- Neurodevelopment
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
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
Arms & Interventions
INO Control (Short iNO)
INO will be given to infants in the control group for the first 7 days of the study gas, then O2 or room air, as clinically appropriate, on the 8th day, until 33 weeks corrected age
Intervention: inhaled nitric oxide
INO Treatment (Long iNO)
The treatment group will receive iNO, combined with O2 or room air, until 33 weeks corrected age.
Intervention: inhaled nitric oxide
INO Treatment (Long iNO)
The treatment group will receive iNO, combined with O2 or room air, until 33 weeks corrected age.
Intervention: oxygen
Outcomes
Primary Outcomes
Neurodevelopment
Time Frame: Two years
Bronchopulmonary Dysplasia (BPD) or Death
Time Frame: 36 weeks of age corrected (BPD) or before discharge (death)
Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations \>90%, or death before discharge
Secondary Outcomes
- Death(through discharge (up to 400 days))
- Bronchopulmonary Dysplasia(36 weeks of age corrected)
- Supplemental Oxygen Use(40 weeks PMA)
- BPD or Death in Infants Weighing < 750g(36 weeks of age corrected (BPD) or before discharge (death))
- BPD or Death in Infants Weighing 750-999g(36 weeks of age corrected (BPD) or before discharge (death))
- BPD or Death in Black Infants(36 weeks of age corrected (BPD) or before discharge (death))