Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-03-14
Brief Title:
Optimization of Routine Obstetric and Neonatal Care in the Management of Severe Perinatal Asphyxia in Term or Near-term Newborns Analysis of Sub-optimal Care
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Optimization of Routine Obstetric and Neonatal Care in the Management of Severe Perinatal Asphyxia in Term or Near-term Newborns Analysis of Sub-optimal Care
Status:
NOT_YET_RECRUITING
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:
OptiNeoCare
Brief Summary:
The purpose of this study is to identify and analyze suboptimal perinatal obstetric-pediatric care in the occurrence and management of severe perinatal asphyxia or death of the newborn at or near term
Perinatal asphyxia is a serious and often unexpected pathology requiring urgent multidisciplinary care obstetric - pediatric - intensive care etc with a high level of technical expertise and care coordination Because of its rarity and complexity it may be subject to suboptimal care
The aim of this study is to provide feedback within the center itself coupled in 13 of cases with a confidential investigation into the search for and understanding of suboptimal care
Primary endpoint
Frequency of optimal or non-optimal maternal and neonatal management of hypoxic-ischemic encephalopathy AIE or neonatal death related to severe perinatal asphyxia
Perinatal asphyxia is a serious and often unexpected pathology requiring urgent multidisciplinary care obstetric - pediatric - intensive care etc with a high level of technical expertise and care coordination Because of its rarity and complexity it may be subject to suboptimal care
The aim of this study is to provide feedback within the center itself coupled in 13 of cases with a confidential investigation into the search for and understanding of suboptimal care
Primary endpoint
Frequency of optimal or non-optimal maternal and neonatal management of hypoxic-ischemic encephalopathy AIE or neonatal death related to severe perinatal asphyxia
Detailed Description:
Perinatal asphyxia at term is a severe pathology that can lead to peripartum death or a birth in vital distress with neurological damage known as anoxic-ischemic encephalopathy AIE representing 16 per thousand births In this unexpected and urgent situation obstetric and neonatal management will have a decisive impact on the neonatal and neurological prognosis of the newborn Despite a significant improvement in prognosis in recent years it remains severe with an estimated risk of death of 15-20 and moderate to severe disability in survivors of 30
The management of severe perinatal asphyxia combines a large number of risks that have been identified as providing suboptimal care in a patient deemed to be vulnerable Batlle showed in an obstetrical clinical audit in the form of a peer review in France in 2010 that half the cases of per-partum asphyxia audited were considered possibly or certainly avoidable Similar results were found in studies in Denmark and Sweden Chevallier et al in France showed that around 35 of newborns requiring hypothermia did not receive it in accordance with French recommendations The aim of analyzing this sub-optimal care is to identify the systematic factors that led to the error and to suggest solutions to avoid similar cases in the future
Corrective action has been taken on the basis of these studies Every case of asphyxia could be used as an example for learning is the title of an article proposing recommendations for obstetric clinical practice based on audits of perinatal asphyxia cases In Queensland the implementation of a national education program on fetal heart rate reading has led to a significant reduction in the incidence of AIS from 250 to 160 events100000 live births In the UK a pragmatic approach has been initiated to improve prognosis in the context of perinatal asphyxia Each Baby Count httpswwwrcogorgukeachbabycounts is a national platform recording every case of perinatal asphyxia and AIE and collecting data on sub-optimal care This work will help to improve the quality of care both locally and nationally
These experiences suggest that the identification of sub-optimal obstetric and neonatal care through a voluntary approach by the centers can lead to improved prevention and management In France serious adverse events are analyzed during morbidity and mortality reviews which remain internal to the facilities and have limited impact at national level The aim of this study is to describe cases of death or HIE to analyze the risk factors and to assess the optimality of care in both obstetrics and pediatrics
The management of severe perinatal asphyxia combines a large number of risks that have been identified as providing suboptimal care in a patient deemed to be vulnerable Batlle showed in an obstetrical clinical audit in the form of a peer review in France in 2010 that half the cases of per-partum asphyxia audited were considered possibly or certainly avoidable Similar results were found in studies in Denmark and Sweden Chevallier et al in France showed that around 35 of newborns requiring hypothermia did not receive it in accordance with French recommendations The aim of analyzing this sub-optimal care is to identify the systematic factors that led to the error and to suggest solutions to avoid similar cases in the future
Corrective action has been taken on the basis of these studies Every case of asphyxia could be used as an example for learning is the title of an article proposing recommendations for obstetric clinical practice based on audits of perinatal asphyxia cases In Queensland the implementation of a national education program on fetal heart rate reading has led to a significant reduction in the incidence of AIS from 250 to 160 events100000 live births In the UK a pragmatic approach has been initiated to improve prognosis in the context of perinatal asphyxia Each Baby Count httpswwwrcogorgukeachbabycounts is a national platform recording every case of perinatal asphyxia and AIE and collecting data on sub-optimal care This work will help to improve the quality of care both locally and nationally
These experiences suggest that the identification of sub-optimal obstetric and neonatal care through a voluntary approach by the centers can lead to improved prevention and management In France serious adverse events are analyzed during morbidity and mortality reviews which remain internal to the facilities and have limited impact at national level The aim of this study is to describe cases of death or HIE to analyze the risk factors and to assess the optimality of care in both obstetrics and pediatrics
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