Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04607109
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2020-10-22
Brief Title:
Long-term Neurodevelopmental Disorders of Prematurely Born Children and Parental Experience
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREMA7
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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None