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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04607109

Acronym

PREMA7

Enrollment

238

Registered

2020-10-29

Start date

2020-11-02

Completion date

2021-07-31

Last updated

2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodevelopmental Abnormality

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to 8 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
EDA score (Evaluation Des fonctions cognitives et des Apprentissages)	7 years old	Evaluation of learning ability by a standardized score (ranging from 15 in maths to 65 in reading, the higher score being the better)

Secondary

Measure	Time frame	Description
RAFAEL follow-up questionnaire reply of parents	8 years old	Questionnaire on parents feelings (with 4 levels from no impact to heavy disturbances of the family life)

Countries

France

Outcome results