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

NCT04607109 | Completed

• 1 other identifier: 2020PI166
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Abnormality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• RAFAEL follow-up questionnaire reply of parents

  8 years old

Eligibility Criteria

• Age: 7 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children born prematurely (\< 33SA) in 2012 and followed up in the RAFAEL network 7 years of age

You may qualify if:

• 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

You may not qualify if:

• Children not able to respond to the EDA evaluation

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Maternity Hospital CHRU

Nancy, 54035, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 29, 2020
• Study Start: November 2, 2020
• Primary Completion: June 30, 2021
• Study Completion: July 31, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

FR (1)