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

NCT00390065 | Completed Phase 4 DMC

• 1 other identifier: MRAP060308
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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.

Conditions

Premature Birth

Keywords

Follow-up; Premature infants; Nitric Oxide; Respiratory function testing; Neurodevelopmental outcomes

Outcome Measures

Primary Outcomes (1)

• Pulmonary Function testing

  at 7 years postnatal age

Secondary Outcomes (1)

• Neurodevelopmental and Cognitive outcomes

  at 7 years of age

Study Arms (3)

Study group

EXPERIMENTAL

Hypoxemic Respiratory Failure treated by Nitric Oxide;

Drug: Nitric Oxide

Control

PLACEBO COMPARATOR

Hypoxemic Respiratory Failure control (Placebo);

Drug: Nitric Oxide

Reference

NO INTERVENTION

Reference (Non hypoxemic respiratory failure)

Interventions

Nitric Oxide DRUG

Early low dose (5ppm) NO inhalation Placebo

Also known as: Reference group (non hypoxemic infants)

Control; Study group

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Parental refusal

Sponsors & Collaborators

• Maternite Regionale Universitaire: lead

Study Sites (2)

Maternite Regionale Universitaire

Nancy, 54042, France

Location

CHU Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (3)

• 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.

  PMID: 15756211 BACKGROUND

• 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.

  PMID: 16824742 BACKGROUND

• 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.

  PMID: 23269119 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Jean-Michel HASCOET, MD

  University of NANCY, France

  STUDY DIRECTOR

• Isabelle RM HAMON, MD, PhD

  Maternite Regionale Universitaire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization in the neonatal period. Blinding maintained at the time of the follow-up study
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Head of Division

Model Details: 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)

Study Record Dates

• First Submitted: October 17, 2006
• First Posted: October 19, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

FR (2)