Viewing Study NCT00390065



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Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00390065
Status: COMPLETED
Last Update Posted: 2017-03-22
First Post: 2006-10-17

Brief Title: Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely
Sponsor: Maternite Regionale Universitaire
Organization: Maternite Regionale Universitaire

Study Overview

Official Title: Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely With Respiratory and Neurodevelopmental Impact of Early Treatment With Inhaled Nitric Oxide
Status: COMPLETED
Status Verified Date: 2017-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Utilization of nitric oxide NO therapy has been related to a trend towards short term improvement in very premature infants A two year follow-up of children treated soon after birth with NO in the neonatal period suggests that a significant improvement in neurodevelopmental outcome might occur This study aims to evaluate follow-up at 6 years in respiratory and neurodevelopmental outcome of children born very prematurely some of them having been treated with nitric oxide in the neonatal period
Detailed Description: Utilization of nitric oxide therapy in the neonatal period has been related to a trend towards short term improvements in respiratory and neurological outcome at 28 days postnatal age or 36 weeks postconceptional age A two year follow-up in children treated soon after birth with NO in the neonatal period suggests that a significant improvement in neurodevelopmental outcome might occur No long term evaluation on respiratory outcome has yet been done This study aims to evaluate respiratory and neurodevelopmental outcome at 6 years of age in children born very prematurely some of them having had Nitric Oxide as a rescue treatment for respiratory distress syndrome

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