Prematurity Related Risks of Cognitive Impairment at School Age

Complications of Prematurity Clinical Trial

— NEORIS  

Official title:

Prematurity Related Risks of Cognitive Impairment at School Age With Regards to Social, Family and Care Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054507
• Other study ID #: MRU.10.11
• Secondary ID: NEORIS
• Status: Completed
• Phase: N/A
• First received: January 27, 2014
• Last updated: April 7, 2015
• Start date: April 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Maternite Regionale Universitaire
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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. 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. 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. An anthropologic study of the utilization of care resources will also be performed within the follow-up network taking care of these children.

Description:

Long term follow-up of vulnerable children such as infants born prematurely are generally studied without taking into account the social, familial and care resources available in the child environment.

Thus, the main purpose of this study is to evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to related social situation, intra family relationships, modalities of care and utilization of care resources.

The study will be divided into 3 parts:

1. Children born prematurely in our 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.

2. The quality of parent and child relationship will be evaluated by standardized questionnaire (Perinatal PTSD Questionnaire). This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.

3. An anthropologic study of care and utilization of care resources will be performed within the follow-up network taking care of these children. This part will use semi-directive interviews of caregivers involved in the follow-up network.

This study should allow to better correlate prematurely born children outcome with their global environment and propose improvements in care resources utilization for a better development.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 11 Years

Eligibility

Inclusion Criteria:

• Former premature infants aged 8-11 years

• School grade appropriate for their age

• Schoolmate control children born at term aged 8-11 years

Exclusion Criteria:

• Any neurological sequelae

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cognition Disorders
• Complications of Prematurity
• Premature Birth

Intervention

Behavioral:
• Cognitive evaluation (Wechsler IV tests)
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.

Locations

Country	Name	City	State
France	M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)	Nancy
France	Maternite Regionale Univesitaire	Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Jean Michel Hascoet	Maternite Regionale Universitaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Utilization of care resources	anthropologic study of care and utilization of care resources using semi-directive interviews of caregivers involved in the follow-up network	Evaluation of care network up to 18 months (within the time for children cognitive evaluation)	No
Primary	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	No
Secondary	Quality of parent and children relationship	Evaluation will be performed by standardized questionnaire (Perinatal PTSD Questionnaire). This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.	Evaluated at 8-11 years of children (at the time of child cognitive evaluation)	No