search
Back to results

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

Primary Purpose

Premature Birth

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Nitric Oxide
Sponsored by
Maternite Regionale Universitaire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Premature Birth focused on measuring Follow-up, Premature infants, Nitric Oxide, Respiratory function testing, Neurodevelopmental outcomes

Eligibility Criteria

6 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Parental refusal

Sites / Locations

  • Maternite Regionale Universitaire
  • CHU Brabois

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Study group

Control

Reference

Arm Description

Hypoxemic Respiratory Failure treated by Nitric Oxide;

Hypoxemic Respiratory Failure control (Placebo);

Reference (Non hypoxemic respiratory failure)

Outcomes

Primary Outcome Measures

Pulmonary Function testing

Secondary Outcome Measures

Neurodevelopmental and Cognitive outcomes

Full Information

First Posted
October 17, 2006
Last Updated
March 21, 2017
Sponsor
Maternite Regionale Universitaire
search

1. Study Identification

Unique Protocol Identification Number
NCT00390065
Brief Title
Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maternite Regionale Universitaire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Follow-up, Premature infants, Nitric Oxide, Respiratory function testing, Neurodevelopmental outcomes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization in the neonatal period. Blinding maintained at the time of the follow-up study
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Hypoxemic Respiratory Failure treated by Nitric Oxide;
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Hypoxemic Respiratory Failure control (Placebo);
Arm Title
Reference
Arm Type
No Intervention
Arm Description
Reference (Non hypoxemic respiratory failure)
Intervention Type
Drug
Intervention Name(s)
Nitric Oxide
Other Intervention Name(s)
Reference group (non hypoxemic infants)
Intervention Description
Early low dose (5ppm) NO inhalation Placebo
Primary Outcome Measure Information:
Title
Pulmonary Function testing
Time Frame
at 7 years postnatal age
Secondary Outcome Measure Information:
Title
Neurodevelopmental and Cognitive outcomes
Time Frame
at 7 years of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All infants included at birth in a randomized controlled trial using early nitric oxide therapy Exclusion Criteria: Parental refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel HASCOET, MD
Organizational Affiliation
University of NANCY, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Isabelle RM HAMON, MD, PhD
Organizational Affiliation
Maternite Regionale Universitaire
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternite Regionale Universitaire
City
Nancy
ZIP/Postal Code
54042
Country
France
Facility Name
CHU Brabois
City
Vandoeuvre
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15756211
Citation
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.
Results Reference
background
PubMed Identifier
16824742
Citation
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.
Results Reference
background
PubMed Identifier
23269119
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs