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

NCT ID: NCT00390065

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-06-30

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.

Conditions

Premature Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Study group

Hypoxemic Respiratory Failure treated by Nitric Oxide;

Group Type: EXPERIMENTAL

Nitric Oxide

Intervention Type: DRUG

Early low dose (5ppm) NO inhalation Placebo

Control

Hypoxemic Respiratory Failure control (Placebo);

Group Type: PLACEBO_COMPARATOR

Nitric Oxide

Intervention Type: DRUG

Early low dose (5ppm) NO inhalation Placebo

Reference

Reference (Non hypoxemic respiratory failure)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nitric Oxide

Early low dose (5ppm) NO inhalation Placebo

Intervention Type: DRUG

Other Intervention Names

Reference group (non hypoxemic infants)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Parental refusal

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maternite Regionale Universitaire

OTHER

Sponsor Role: lead

Responsible Party

Jean Michel Hascoet

Professor - Head of Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Michel HASCOET, MD

Role: STUDY_DIRECTOR

University of NANCY, France

Isabelle RM HAMON, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maternite Regionale Universitaire

Locations

Maternite Regionale Universitaire

Nancy, , France

CHU Brabois

Vandœuvre-lès-Nancy, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 15756211 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16824742 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23269119 (View on PubMed)

Other Identifiers

MRAP060308

Identifier Type: -

Identifier Source: org_study_id