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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00390065
First Posted: October 19, 2006
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jean Michel Hascoet, Maternite Regionale Universitaire
  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: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Randomization in the neonatal period. Blinding maintained at the time of the follow-up study
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 Jean Michel Hascoet, Maternite Regionale Universitaire:

Primary Outcome Measures:
  • Pulmonary Function testing [ Time Frame: at 7 years postnatal age ]

Secondary Outcome Measures:
  • Neurodevelopmental and Cognitive outcomes [ Time Frame: at 7 years of age ]

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
Experimental: Study group
Hypoxemic Respiratory Failure treated by Nitric Oxide;
Drug: Nitric Oxide
Early low dose (5ppm) NO inhalation Placebo
Other Name: Reference group (non hypoxemic infants)
Placebo Comparator: Control
Hypoxemic Respiratory Failure control (Placebo);
Drug: Nitric Oxide
Early low dose (5ppm) NO inhalation Placebo
Other Name: Reference group (non hypoxemic infants)
No Intervention: Reference
Reference (Non hypoxemic respiratory failure)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean Michel Hascoet, Professor - Head of Division, Maternite Regionale Universitaire
ClinicalTrials.gov Identifier: NCT00390065     History of Changes
Other Study ID Numbers: MRAP060308
First Submitted: October 17, 2006
First Posted: October 19, 2006
Last Update Posted: March 22, 2017
Last Verified: March 2017

Keywords provided by Jean Michel Hascoet, 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
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents