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Completed

NCT Number: NCT04607109

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

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.

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Key information

Age range

7 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maternity Hospital CHRU

Nancy, 54035, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. EDA score (Evaluation Des fonctions cognitives et des Apprentissages)

    Time frame: 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 outcomes

  1. RAFAEL follow-up questionnaire reply of parents

    Time frame: 8 years old

    Questionnaire on parents feelings (with 4 levels from no impact to heavy disturbances of the family life)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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

Acronym: PREMA7

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2020
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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