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

This study has been completed.
Sponsor:
Information provided by:
Maternite Regionale Universitaire
ClinicalTrials.gov Identifier:
NCT00390065
First received: October 17, 2006
Last updated: September 18, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Premature Birth
Drug: Nitric Oxide
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Maternite Regionale Universitaire:

Primary Outcome Measures:
  • Pulmonary Function testing [ Time Frame: at 7 years postnatal age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurodevelopmental and Cognitive outcomes [ Time Frame: at 7 years of age ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: October 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
3
Hypoxemic Respiratory Failure treated by Nitric Oxide; Hypoxemic Respiratory Failure control (Placebo); Reference (Non hypoxemic respiratory failure)
Drug: Nitric Oxide
Early low dose (5ppm) NO inhalation Placebo
Other Name: Reference group (non hypoxemic infants)

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

Ages Eligible for Study:   6 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Parental refusal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390065

Locations
France
Maternite Regionale Universitaire
Nancy, France, 54042
CHU Brabois
Vandoeuvre, France, 54500
Sponsors and Collaborators
Maternite Regionale Universitaire
Investigators
Study Director: Jean-Michel HASCOET, MD University of NANCY, France
Principal Investigator: Isabelle RM HAMON, MD, PhD Maternite Regionale Universitaire
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof JM HASCOET, Maternite Regionale Universitaire
ClinicalTrials.gov Identifier: NCT00390065     History of Changes
Other Study ID Numbers: MRAP060308
Study First Received: October 17, 2006
Last Updated: September 18, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Maternite Regionale Universitaire:
Follow-up
Premature infants
Nitric Oxide
Respiratory function testing
Neurodevelopmental outcomes

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on April 22, 2014