Study aims to uncover gaps in emergency care for newborns with oxygen deprivation
NCT ID NCT06322732
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study looks at how well hospitals manage severe oxygen deprivation (asphyxia) in newborns at or near full term. Researchers will review care given during labor and after birth to find where improvements can be made. The goal is to help doctors and nurses provide better, faster care to prevent brain injury or death in these fragile infants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could identify gaps in care and lead to better protocols for managing severe perinatal asphyxia in newborns.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly test new therapies. Results may not apply to all hospitals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 336 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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)
- Ages
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Up to 1 month
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hôpital Armand Tousseau. Service de gynécologie obstétrique. 26 avenue du Dr Arnold Netter
RECRUITINGParis, Île-de-France Region, 75012, France
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