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

March 21, 2017 updated by: Jean Michel Hascoet, Maternite Regionale Universitaire

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54042
        • Maternite Regionale Universitaire
      • Vandoeuvre, France, 54500
        • Chu Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Parental refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary Function testing
Time Frame: at 7 years postnatal age
at 7 years postnatal age

Secondary Outcome Measures

Outcome Measure
Time Frame
Neurodevelopmental and Cognitive outcomes
Time Frame: at 7 years of age
at 7 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maternite Regionale Universitaire

Investigators

  • Study Director: Jean-Michel HASCOET, MD, University of NANCY, France
  • Principal Investigator: Isabelle RM HAMON, MD, PhD, Maternite Regionale Universitaire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 17, 2006

First Posted (Estimate)

October 19, 2006

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRAP060308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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