Optimization of routine obstetric and neonatal care for severe perinatal asphyxia at term or near-term babies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study examines cases of severe perinatal asphyxia or related neonatal death in term or near-term newborns and analyzes how obstetric and neonatal care was managed. It aims to identify systematic factors that contribute to suboptimal care and to provide feedback within centers, with some cases including confidential investigations. The focus is on understanding the care pathways that influence outcomes such as hypoxic-ischemic encephalopathy and neonatal mortality. Although interventions are not specified, the study seeks to highlight gaps and propose areas for improvement in multidisciplinary, high-urgency settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

\- 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

1. 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
2. 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).

Exclusion Criteria

* 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's running

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

Study contacts

• Principal investigator: Gilles KAYEM, MD, PhD — Hôpital Armand Trousseau - Service de gynécologie obstétrique. 26 avenue du Dr Arnold Netter.75012. Paris
• Study coordinator: Pierre DELORME, MD, PhD
• Email: pierre.delorme@aphp.fr
• Phone: 01 44 73 51 20

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.