Follow-Up at 6 Years of a Cohort of Children Born Very Pr... | NCT00390065

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

NCT00390065

Sponsor

Maternite Regionale Universitaire

Status

Completed

Last Update Posted

Mar 22, 2017Actual

Enrollment

108Actual

Phase

Phase 4

Conditions

Premature Birth

Interventions

Nitric Oxide

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Oct 17, 2006

First Submission Date that Met QC Criteria

Oct 17, 2006

First Posted Date

Oct 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2017

Last Update Posted Date

Mar 22, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jean Michel Hascoet, Professor - Head of Division, Maternite Regionale UniversitairePrincipal Investigator

Lead Sponsor

Maternite Regionale UniversitaireOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Hypoxemic Respiratory Failure treated by Nitric Oxide;	Drug: Nitric Oxide
Control	Placebo Comparator	Hypoxemic Respiratory Failure control (Placebo);	Drug: Nitric Oxide
Reference	No Intervention	Reference (Non hypoxemic respiratory failure)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nitric Oxide	Drug	Early low dose (5ppm) NO inhalation Placebo	Control Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pulmonary Function testing		at 7 years postnatal age

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Parental refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maternite Regionale Universitaire		Nancy		54042	France
CHU Brabois

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15756211	Background	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.
16824742	Background

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D026361	Reactive Nitrogen Species
D005609	Free Radicals
D007287	Inorganic Chemicals
D009589	Nitrogen Oxides