Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Observational

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

NCT06322732 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-05-05
Last updated
2026-07-01

Condition(s) studied

Perinatal Asphyxia

Study 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 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

Sex
ALL
Min age
—
Max age
1 Month
Healthy volunteers
No
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

Primary outcome measure(s)

  • sub-optimal perinatal care — 1 year
    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.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Armand Tousseau. Service de gynécologie obstétrique. 26 avenue du Dr Arnold Netter Paris Île-de-France Region Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06322732 on ClinicalTrials.gov ↗ ← All trials in France