About this trial
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 1/3 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
moderate to severe anoxic-ischemic encephalopathy OR
a newborn hospitalized in the first week of life for hypoxic-ischemic encephalopathy or convulsions related to a perpartum event.
a pH (arterial or, failing that, venous) ≤ 7.10 or base deficit ≥ 16mmol/L or lactates ≥ 11mmol/L during the first three hours of life OR
In the absence of biological documentation of metabolic acidosis, an Apgar ≤ 5 to 5 minutes of life or the need for neonatal resuscitation (ventilatory support at birth and Apgar score ≤ 7 to 10 minutes of life).
Disqualifiers
Fetal death in utero prior to hospital admission
Medical termination of pregnancy
Severe malformations with potential impact on child survival and development.
Neonatal encephalopathy not due to perinatal asphyxia
Trial population
Cases of severe perinatal asphyxia will be drawn from the general population of full-term or near-term deliveries in the participating network's maternity units, whether public, private or home birth, and for all types of maternity unit (type 1 - 2 or 3)
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
sub-optimal perinatal care
Identify and analyze sub-optimal perinatal (obstetric-pediatric) care in the occurrence and management of severe perinatal asphyxia or death of the newborn at or near term.
Secondary outcomes
Frequency of suboptimal care
Describe the frequency and context of HIE or neonatal death secondary to severe perinatal asphyxia.
Relationship
Evaluate possible relationships between suboptimal care and the occurrence of severe perinatal asphyxia
Outcome
Evaluate possible relationships between suboptimal care and the outcome of newborns in terms of mortality and neurological morbidity
Characteristics of suboptimal care
Analyze the characteristics of sub-optimal care identified by experts
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator