Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely

Phase 4

Completed

• Conditions: Premature Birth
• Interventions: Drug: Nitric Oxide

• Registration Number: NCT00390065
• Lead Sponsor: Maternite Regionale Universitaire

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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-17
• Study First Posted: 2006-10-19
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• All infants included at birth in a randomized controlled trial using early nitric oxide therapy

Exclusion Criteria

• Parental refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Nitric Oxide	Hypoxemic Respiratory Failure treated by Nitric Oxide;
Control	Nitric Oxide	Hypoxemic Respiratory Failure control (Placebo);

Primary Outcome Measures

Name	Time	Method
Pulmonary Function testing	at 7 years postnatal age

Secondary Outcome Measures

Name	Time	Method
Neurodevelopmental and Cognitive outcomes	at 7 years of age

Trial Locations

Locations (2)

Maternite Regionale Universitaire; 🇫🇷 Nancy, France

CHU Brabois; 🇫🇷 Vandoeuvre, France