Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391476
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2024-04-04
Brief Title:
Prematurity at the Limit of Viability
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Morbi-mortality and Development at 2 Years in Infants Born at the Limit of Viability
Status:
COMPLETED
Status Verified Date:
2024-04
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:
PRELIVIA
Brief Summary:
Advancements in perinatal care have significantly improved the survival of extremely premature infants establishing a viability threshold below 25 weeks gestational age GA However management at the limit of viability poses ethical and decision-making problems for health-care professionals They grapple with the delicate balance between potential survival and long-term disabilities
These decisions as well as the information given to families are based on knowledge of the prognosis as assessed by national and international epidemiological studies Healthcare professionals rely on population-based estimations but face discrepancies in predicting outcomes because there are significant variation depending on perinatal center and country where infants are hospitalized In the large French epidemiological study 96 of livebirths included were born at 22-25 wks and only 38 survived
In the neonatology department of the croix rousse these infants have been actively cared for for many years which has allowed the development of specific skills that are essential for the proper management of these very high-risk patients Furthermore EPIPAGE 2 included data from centers where perinatal management was probably not very active at these extreme ages It results in worse neonatal outcomes as evaluated at the national level than outcomes data evaluated at the neonatal intensive care unit of Croix-Rousse hospital Using data from EPIPAGE 2 study for clinical decision could lead to avoid active care at the for some infants at the limit of viability It is needed to obtain complete evaluation of neonatal outcomes of infants hospitalized at the Croix-Rousse hospital so that clinicians may rely on actualized data related to the practices in their perinatal center It is also needed to compare outcomes with data from large national and international cohorts to identify and quantify differences Data about later neurodevelopment outcomes at 2 years are also needed as it can taken in consideration in decision-making process
These decisions as well as the information given to families are based on knowledge of the prognosis as assessed by national and international epidemiological studies Healthcare professionals rely on population-based estimations but face discrepancies in predicting outcomes because there are significant variation depending on perinatal center and country where infants are hospitalized In the large French epidemiological study 96 of livebirths included were born at 22-25 wks and only 38 survived
In the neonatology department of the croix rousse these infants have been actively cared for for many years which has allowed the development of specific skills that are essential for the proper management of these very high-risk patients Furthermore EPIPAGE 2 included data from centers where perinatal management was probably not very active at these extreme ages It results in worse neonatal outcomes as evaluated at the national level than outcomes data evaluated at the neonatal intensive care unit of Croix-Rousse hospital Using data from EPIPAGE 2 study for clinical decision could lead to avoid active care at the for some infants at the limit of viability It is needed to obtain complete evaluation of neonatal outcomes of infants hospitalized at the Croix-Rousse hospital so that clinicians may rely on actualized data related to the practices in their perinatal center It is also needed to compare outcomes with data from large national and international cohorts to identify and quantify differences Data about later neurodevelopment outcomes at 2 years are also needed as it can taken in consideration in decision-making process
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