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

Recruiting now

Conditions studied: Perinatal Asphyxia

In brief

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.

Key facts

Study ID

NCT06322732

Run by

Assistance Publique - Hôpitaux de Paris

People needed

336

Starts

2025-05-05

Expected to finish

2027-01-01

Last updated by the study team

2026-07-01

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newborn at or near term (≥ 36 weeks of amenorrhea), considered to be alive at the onset of labor and presenting severe perinatal asphyxia
• Severe perinatal asphyxia is considered if
• Severity in its impact on the newborn:
• a neonatal death during the initial hospitalization, since birth and before a possible return home, before D28 ".
• OR
• 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.
• AND
• Biological perinatal asphyxia:
• 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).
• If none of the biological elements are available in the file, keep the clinical inclusion criteria below (In the absence of biological and clinical Apgar data (home delivery type), inclusion may be based on neonatal outcome (death - hypoxic ischemic encephalopathy - neonatal convulsions).

You may not qualify if…

• 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

Where it is running

• Hôpital Armand Tousseau. Service de gynécologie obstétrique. 26 avenue du Dr Arnold Netter — Paris, Île-de-France Region, France (enrolling)

Full record on ClinicalTrials.gov

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