NCT04607109: PREMA7

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

Completed Last updated 4 March 2022

What this trial tests

trial in Neurodevelopmental Abnormality in 238 participants. Completed in 31 July 2021.

Timeline

2 November 2020

Primary endpoint
30 June 2021

31 July 2021

Quick facts

Lead sponsor	Central Hospital, Nancy, France
Status	Completed
Study type	OBSERVATIONAL
Enrollment	238
Start date	2 November 2020
Primary completion	30 June 2021
Estimated completion	31 July 2021
Sites	1 location across France

Conditions studied

• Neurodevelopmental Abnormality — all drugs for Neurodevelopmental Abnormality →

Sponsor

Central Hospital, Nancy, France

Who can join

Adults 7 to 8, any sex, with Neurodevelopmental Abnormality. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neurodevelopment at seven years and parents' feelings of prematurely born children.
   Mercier C, Deforge H, Hascoët JM. · · 2022 · cited 5× · PMID 36545662 · DOI 10.3389/fped.2022.1004785