NCT02054507

Brief Summary

The main purpose of this study is to better evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to social situation, intra family relationships, and modalities of care. The study will be divided into 3 parts:

  1. 1.Children born prematurely in our level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine cognitive test. The relationships between cognitive scores and neonatal characteristics will be determined and compared to the results of schoolmates born at term.
  2. 2.The quality of parent and child relationship will be evaluated by a standardized questionnaire allowing the evaluation of persistent stress trauma related to premature birth.
  3. 3.An anthropologic study of the utilization of care resources will also be performed within the follow-up network taking care of these children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

January 27, 2014

Last Update Submit

April 7, 2015

Conditions

Complications of Prematurity

Keywords

ChildrenCognitive outcomePrematurityCare NetworkOutpatient follow-up of cognitive developmentCare resources

Outcome Measures

Primary Outcomes (1)

  • Cognitive and executive functions at school age in prematurely born children

    Assessment by WECHSLER IV tests of children born prematurely without neurological or sensorial sequelae, and without psychological difficulties; All in school grade appropriate for their ages Controls : children born at term, matched for age and school grade.

    Children at the age of 8-11 years

Secondary Outcomes (1)

  • Quality of parent and children relationship

    Evaluated at 8-11 years of children (at the time of child cognitive evaluation)

Other Outcomes (1)

  • Utilization of care resources

    Evaluation of care network up to 18 months (within the time for children cognitive evaluation)

Study Arms (1)

Former premature infants

NO INTERVENTION

Cognitive and executive evaluation by Wechsler IV tests

Behavioral: Cognitive evaluation (Wechsler IV tests)

Interventions

Cognitive evaluation (Wechsler IV tests)BEHAVIORAL

Children born prematurely in a level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine test (WISC IV). The relationship between cognitive scores and neonatal characteristics will be determined and compared with the results of schoolmate control children, born at term.

Former premature infants

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Former premature infants aged 8-11 years
  • School grade appropriate for their age
  • Schoolmate control children born at term aged 8-11 years

You may not qualify if:

  • Any neurological sequelae

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)

Nancy, 54001, France

Location

Maternite Regionale Univesitaire

Nancy, 54035, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jean-Michel HASCOET, MD

    Maternite Regionale Universitaire CHU NANCY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 27, 2014

First Posted

February 4, 2014

Study Start

April 1, 2013

Primary Completion

July 1, 2014

Study Completion

March 1, 2015

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

FR(2)