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
Overview
- Phase
- Phase 4
- Intervention
- Nitric Oxide
- Conditions
- Premature Birth
- Sponsor
- Maternite Regionale Universitaire
- Enrollment
- 108
- Locations
- 2
- Primary Endpoint
- Pulmonary Function testing
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Jean Michel Hascoet
Professor - Head of Division
Maternite Regionale Universitaire
Eligibility Criteria
Inclusion Criteria
- •All infants included at birth in a randomized controlled trial using early nitric oxide therapy
Exclusion Criteria
- •Parental refusal
Arms & Interventions
Study group
Hypoxemic Respiratory Failure treated by Nitric Oxide;
Intervention: Nitric Oxide
Control
Hypoxemic Respiratory Failure control (Placebo);
Intervention: Nitric Oxide
Outcomes
Primary Outcomes
Pulmonary Function testing
Time Frame: at 7 years postnatal age
Secondary Outcomes
- Neurodevelopmental and Cognitive outcomes(at 7 years of age)