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 | Not Yet Recruiting

• 1 other identifier: APHP191125
• Study Type: observational
• Target: 336
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Perinatal Asphyxia

Keywords

Hypoxic-ischemic encephalopathy; perinatal asphyxia; neonatal death; suboptimal care; confidential inquiry

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (6)

• Frequency of suboptimal care

  1 year

• Relationship

  1 year

• Outcome

  1 year

• Characteristics of suboptimal care

  1 year

• Determinantes of suboptimal care

  1 year

Study Arms (1)

Newborn at or near term

Newborn at or near term (≥ 36 weeks of amenorrhea), considered to be alive at the onset of labor and presenting severe perinatal asphyxia

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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)

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 ".
• 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).

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Related Publications (1)

• Guellec I, Ancel PY, Abdoul H, Garabedian C, Verspyck E, Huissoud C, Delnaud M, Graesslin B, Desplanches T, Cambonie G, Tourneux P, Debillon T, Mitha A, Loron G, Favrais G, Badr M, Chapeliere S, Brasseur-Daudruy M, Gonzalez Estevez M, Rigouzzo A, Delorme P, Kayem G. OptiNeoCare: optimisation of routine care in the management of severe perinatal asphyxia in full-term or near-term newborns - study protocol for analysis of suboptimal care by confidential inquiries and e-self report. BMJ Open. 2025 Jul 5;15(7):e106093. doi: 10.1136/bmjopen-2025-106093.

  PMID: 40617609 DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Perinatal Death

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes

Study Officials

• Isabelle GUELLEC-RENNE, MD, PhD

  Intensive care unit - L'archet University Hospital of Nice Côte d'Azur

  STUDY DIRECTOR

• Gilles KAYEM, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles KAYEM, MD, PhD

CONTACT

+33 1 44 73 51 20; gilles.kayem@aphp.fr

Charly LARRIEU, PHD

CONTACT

+33 1 58 41 34 78; charly.larrieu@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share