Clinical trial NCT00390065: Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premature Birth
Keywords: Follow-up
Premature infants
Nitric Oxide
Respiratory function testing
Neurodevelopmental outcomes
Lead sponsor: Maternite Regionale Universitaire
Sponsor class: OTHER
First posted: 2006-10-19
Enrollment: 108
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a follow-up study, at 6 years of age, of infants randomized in the neonatal period with one other group studied as a reference group (ie 3 groups)
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Parental refusal

Primary outcomes:
measure: Pulmonary Function testing
timeFrame: at 7 years postnatal age
Secondary outcomes:
measure: Neurodevelopmental and Cognitive outcomes
timeFrame: at 7 years of age
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternite Regionale Universitaire
city: Vandoeuvre
country: France
facility: CHU Brabois
Study officials:
affiliation: University of NANCY, France
name: Jean-Michel HASCOET, MD
role: STUDY_DIRECTOR
affiliation: Maternite Regionale Universitaire
name: Isabelle RM HAMON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hascoet JM, Fresson J, Claris O, Hamon I, Lombet J, Liska A, Cantagrel S, Al Hosri J, Thiriez G, Valdes V, Vittu G, Egreteau L, Henrot A, Buchweiller MC, Onody P. The safety and efficacy of nitric oxide therapy in premature infants. J Pediatr. 2005 Mar;146(3):318-23. doi: 10.1016/j.jpeds.2004.10.019.
citation: Deforge H, Andre M, Hascoet JM, Toniolo AM, Demange V, Fresson J. [Cognitive development and attention performances at school age of "normal" prematurely born children]. Arch Pediatr. 2006 Sep;13(9):1195-201. doi: 10.1016/j.arcped.2006.05.015. Epub 2006 Jul 7. French.
citation: Hamon I, Varechova S, Vieux R, Ioan I, Bonabel C, Schweitzer C, Hascoet JM, Marchal F. Exercise-induced bronchoconstriction in school-age children born extremely preterm. Pediatr Res. 2013 Apr;73(4 Pt 1):464-8. doi: 10.1038/pr.2012.202. Epub 2012 Dec 26.