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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014