NCT00515281

Inhaled Nitric Oxide and Neuroprotection in Premature Infants

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 2 Hours – 72 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Prematurity
• Bronchopulmonary Dysplasia
• Intraventricular Hemorrhage
• Periventricular Leukomalacia

Interventions

Type	Name	Description
DRUG	inhaled nitric oxide	The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm.
DRUG	oxygen	The amount of gas will be carefully controlled and adjusted to the level that best improves the function of the subject's lungs. Subjects in the control arm of the study will receive oxygen beginning on the 8th day of the study until he/she reaches 33 weeks of gestation.

Timeline

• Start date: 2008-05-01
• Primary completion: 2023-06-07
• Completion: 2023-11-28
• First posted: 2007-08-13
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

1 site across 1 country: United States