Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00515281
Status:
TERMINATED
Last Update Posted:
2023-05-09
First Post:
2007-08-09
Brief Title:
Inhaled Nitric Oxide and Neuroprotection in Premature Infants
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Inhaled Nitric Oxide and Neuroprotection in Premature Infants
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The pace of patient enrolledment forced recruitment to stop after 273 patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOVA2
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None