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NCT00390065 Clinical Trial

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

Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00390065
Other study ID # MRAP060308
Secondary ID
Status Completed
Phase Phase 4
First received October 17, 2006
Last updated March 21, 2017
Start date October 2006
Est. completion date June 2009

Study information
Verified date March 2017
Source Maternite Regionale Universitaire
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 108
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 6 Years to 8 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Parental refusal

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nitric Oxide
Early low dose (5ppm) NO inhalation Placebo

Locations
Country Name City State
France Maternite Regionale Universitaire Nancy
France CHU Brabois Vandoeuvre

Sponsors (1)
Lead Sponsor Collaborator
Maternite Regionale Universitaire

Country where clinical trial is conducted

France, 

References & Publications (2)

Deforge H, André M, Hascoët 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. French. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pulmonary Function testing at 7 years postnatal age
Secondary Neurodevelopmental and Cognitive outcomes at 7 years of age
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