Perinatal AsphyxiaOptiNeoCareNCT06322732
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
An observational study of Perinatal Asphyxia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Perinatal Asphyxia
- How many people
- 336 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 month
- All sexes
- No healthy volunteers
- Child
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)
Who may be able to join
- 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
Show all 12Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Armand Tousseau. Service de gynécologie obstétrique. 26 avenue du Dr Arnold Netter
Paris, Île-de-France Region, 75012
About this study
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.
Read more
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.
Read the detailed description
Perinatal asphyxia at term is a severe pathology that can lead to peripartum death or a birth in vital distress with neurological damage known as anoxic-ischemic encephalopathy (AIE), representing 1.6 per thousand births. In this unexpected and urgent situation, obstetric and neonatal management will have a decisive impact on the neonatal and neurological prognosis of the newborn. Despite a significant improvement in prognosis in recent years, it remains severe, with an estimated risk of death of 15-20% and moderate to severe disability in survivors of 30%.
The management of severe perinatal asphyxia combines a large number of risks that have been identified as providing suboptimal care in a patient deemed to be vulnerable. Batlle showed in an obstetrical clinical audit, in the form of a peer review in France in 2010, that half the cases of per-partum asphyxia audited were considered "possibly or certainly avoidable". Similar results were found in studies in Denmark and Sweden. Chevallier et al in France showed that around 35% of newborns requiring hypothermia did not receive it in accordance with French recommendations. The aim of analyzing this sub-optimal care is to identify the systematic factors that led to the error, and to suggest solutions to avoid similar cases in the future.
Corrective action has been taken on the basis of these studies: "Every case of asphyxia could be used as an example for learning" is the title of an article proposing recommendations for obstetric clinical practice based on audits of perinatal asphyxia cases. In Queensland, the implementation of a national education program on fetal heart rate reading has led to a significant reduction in the incidence of AIS from 250 to 160 events/100,000 live births. In the UK, a pragmatic approach has been initiated to improve prognosis in the context of perinatal asphyxia. "Each Baby Count" https://www.rcog.org.uk/eachbabycounts, is a national platform recording every case of perinatal asphyxia and AIE, and collecting data on sub-optimal care. This work will help to improve the quality of care both locally and nationally.
These experiences suggest that the identification of sub-optimal obstetric and neonatal care through a voluntary approach by the centers can lead to improved prevention and management. In France, serious adverse events are analyzed during morbidity and mortality reviews, which remain internal to the facilities and have limited impact at national level. The aim of this study is to describe cases of death or HIE, to analyze the risk factors and to assess the optimality of care in both obstetrics and pediatrics.
- Conditions
- Perinatal Asphyxia
- Keywords
- Hypoxic-ischemic encephalopathy, perinatal asphyxia, neonatal death, suboptimal care, confidential inquiry
- Medical subject headings
- Hypoxia-Ischemia, Brain, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (6)
Frequency of suboptimal care
Describe the frequency and context of HIE or neonatal death secondary to severe perinatal asphyxia.
Measured: 1 year
Relationship
Evaluate possible relationships between suboptimal care and the occurrence of severe perinatal asphyxia
Measured: 1 year
Outcome
Evaluate possible relationships between suboptimal care and the outcome of newborns in terms of mortality and neurological morbidity
Measured: 1 year
Characteristics of suboptimal care
Analyze the characteristics of sub-optimal care identified by experts
Measured: 1 year
Determinantes of suboptimal care
Assessing the determinants of suboptimal care
Measured: 1 year
Ad-hoc survey
Evaluate the relevance of an ad-hoc survey versus a confidential survey on the analysis of sub-optimal care.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start5 May 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal AsphyxiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Isabelle GUELLEC-RENNE, MD, PhD, Study director, Intensive care unit - L'archet University Hospital of Nice Côte d'AzurGilles KAYEM, MD, PhD, Principal investigator, Hôpital Armand Trousseau - Service de gynécologie obstétrique. 26 avenue du Dr Arnold Netter.75012. Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322732
- Sponsor's protocol ID
- APHP191125
- Acronym
- OptiNeoCare
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Undecided
Publications
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.
PubMed 40617609
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06322732
- Acronym / sponsor ID
- OptiNeoCare / APHP191125
- Conditions
- Perinatal Asphyxia
- Keywords
- Hypoxic-ischemic encephalopathy, perinatal asphyxia, neonatal death, suboptimal care, confidential inquiry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 5 May 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Perinatal asphyxia at term is a severe pathology that can lead to peripartum death or a birth in vital distress with neurological damage known as anoxic-ischemic encephalopathy (AIE), representing 1.6 per thousand births. In this unexpected and urgent situation, obstetric and neonatal management will have a decisive impact on the neonatal and neurological prognosis of the newborn. Despite a significant improvement in prognosis in recent years, it remains severe, with an estimated risk of death of 15-20% and moderate to severe disability in survivors of 30%.
The management of severe perinatal asphyxia combines a large number of risks that have been identified as providing suboptimal care in a patient deemed to be vulnerable. Batlle showed in an obstetrical clinical audit, in the form of a peer review in France in 2010, that half the cases of per-partum asphyxia audited were considered "possibly or certainly avoidable". Similar results were found in studies in Denmark and Sweden. Chevallier et al in France showed that around 35% of newborns requiring hypothermia did not receive it in accordance with French recommendations. The aim of analyzing this sub-optimal care is to identify the systematic factors that led to the error, and to suggest solutions to avoid similar cases in the future.
Corrective action has been taken on the basis of these studies: "Every case of asphyxia could be used as an example for learning" is the title of an article proposing recommendations for obstetric clinical practice based on audits of perinatal asphyxia cases. In Queensland, the implementation of a national education program on fetal heart rate reading has led to a significant reduction in the incidence of AIS from 250 to 160 events/100,000 live births. In the UK, a pragmatic approach has been initiated to improve prognosis in the context of perinatal asphyxia. "Each Baby Count" https://www.rcog.org.uk/eachbabycounts, is a national platform recording every case of perinatal asphyxia and AIE, and collecting data on sub-optimal care. This work will help to improve the quality of care both locally and nationally.
These experiences suggest that the identification of sub-optimal obstetric and neonatal care through a voluntary approach by the centers can lead to improved prevention and management. In France, serious adverse events are analyzed during morbidity and mortality reviews, which remain internal to the facilities and have limited impact at national level. The aim of this study is to describe cases of death or HIE, to analyze the risk factors and to assess the optimality of care in both obstetrics and pediatrics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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)
Key inclusion criteria (12 listed)
- 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:
- OR
- AND
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sub-optimal perinatal care
Time frame: 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.
6 secondary outcomes
Frequency of suboptimal care
Time frame: 1 year
Relationship
Time frame: 1 year
Outcome
Time frame: 1 year
Characteristics of suboptimal care
Time frame: 1 year
Determinantes of suboptimal care
Time frame: 1 year
Ad-hoc survey
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Derived from this study: PubMed 40617609Guellec 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.
- Individual participant dataSharing planned: Yes. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle GUELLEC-RENNE, MD, PhD study director
Intensive care unit - L'archet University Hospital of Nice Côte d'Azur
Gilles KAYEM, MD, PhD principal investigator
Hôpital Armand Trousseau - Service de gynécologie obstétrique. 26 avenue du Dr Arnold Netter.75012. Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Asphyxia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre DELORME, MD, PhD (01 44 73 51 20 ext. +33, pierre.delorme@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sub-optimal perinatal care (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06322732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.