Long-term Neurodevelopmental Disorders of Prematurely Born Children and Parental Experience

Neurodevelopmental Abnormality Clinical Trial

— PREMA7  

Official title:

Neurodevelopmental Assessment and Parents Feelings at 7-8 Years of Age for Prematurely Born Children Involved in the Réseau Périnatal Lorrain Follow-up Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607109
• Other study ID #: 2020PI166
• Status: Completed
• Start date: November 2, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Thanks to the evolution in knowledge and technical advances in premature newborn intensive care, the survival of very premature infants is now possible. However, prognosis remain sometimes uncertain.

In 2011, the Epipage 2 study showed a significant improvement as compared with the 1997 Epipage1 study with a decrease in mortality and an increase of the survival rate without severe morbidity of 14% for preterm babies born between 25 and 29 weeks and 6% for babies born between 30 and 31 weeks.

However, surviving babies without initial major deficiencies, may later show problems in terms of growth, sensory - motor and/or neuro-psychologic development. This untoward evolution lead to social and family interaction disorders and school difficulties.

In this context, a perinatal care network was created for each Region in France, making it possible to take care of these vulnerable children early on and all along their development. A retrospective study will evaluate 97 pre-term babies born before 33 weeks in 2012 and who are taken care of at Nancy as part of the Lorraine regional network program "Rafael" until they are 7 years old.

The objective is to evaluate objectively the neurocognitive and school abilities of these children at the age of 7.

At 8 years of age, a secondary measure of outcome will be the impact of the eventual neurocognitive consequences on the quality of their family life, on the behavior of the child and the parents' feelings. This way more options to improve the way they are taken care of will be available.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: July 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 8 Years

Eligibility

Inclusion Criteria:

• all children prematurely born between 24 and 33 completed week during 2012

• and involved in the Lorraine Perinatal Follow-up program at 7 years old

Exclusion Criteria:

• Children not able to respond to the EDA evaluation

Related Conditions & MeSH terms

• Congenital Abnormalities
• Neurodevelopmental Abnormality

Locations

Country	Name	City	State
France	Maternity Hospital CHRU	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EDA score (Evaluation Des fonctions cognitives et des Apprentissages)	Evaluation of learning ability by a standardized score (ranging from 15 in maths to 65 in reading, the higher score being the better)	7 years old
Secondary	RAFAEL follow-up questionnaire reply of parents	Questionnaire on parents feelings (with 4 levels from no impact to heavy disturbances of the family life)	8 years old