Neonatal Acidemia and HypoxiaRCFHypANCT07333599
Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00
An observational study of Neonatal Acidemia and Hypoxia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Severe neonatal acidosis is an identified risk factor for neonatal encephalopathies and severe neurological sequelae such as cerebral palsy. While intrapartum origin of such deterioration is rare (approximately 20% of adverse outcomes in term infants), screening for hypoxia that can lead to the development of severe… Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Neonatal Acidemia and Hypoxia
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2025to 14 Aug 2026
- 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 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: Adult woman (≥ 18 years) with singleton pregnancy and cord arterial pH < 7.00
Who may be able to join
- Adult woman (≥ 18 years)
- Treated at Strasbourg University Hospital between January 1, 2014, and December 31, 2024
- Singleton pregnancy
- Cord arterial pH < 7.00
Who cannot join
- Gestational age < 37 weeks
- Known congenital malformation
- Intrauterine fetal death diagnosed upon admission
- No cardiotocographic recording
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
Service de Gynécologie-Obstétrique - CHU de Strasbourg - France
Strasbourg, 67091
Georges-Emmanuel ROTH, Midwife, 33.3.69.55.35.46, georges-emmanuel.roth@chru-strasbourg.fr
Georges-Emmanuel ROTH, Midwife
About this study
Severe neonatal acidosis is an identified risk factor for neonatal encephalopathies and severe neurological sequelae such as cerebral palsy. While intrapartum origin of such deterioration is rare (approximately 20% of adverse outcomes in term infants), screening for hypoxia that can lead to the development of severe acidosis remains inadequate. This results in both delays in diagnosis and/or intervention, and a parallel increase in obstetric interventions (cesarean sections and operative vaginal deliveries) sometimes performed with inappropriate indications, thus contributing to unnecessary maternal and neonatal comorbidities. Difficulties in analyzing fetal heart rate (FHR) patterns are identified as an independent risk factor, particularly due to significant inter- and intra-observer variability, in an examination that is nevertheless central to assessing fetal well-being during labor. An FHR analysis based on a thorough understanding of the physiology of fetal adaptation to hypoxia could allow for better recognition of situations where fetal compensation for hypoxic stress is no longer possible, when adaptive mechanisms are exhausted. Given that FHR interpretation errors are implicated in 35 to 50% of adverse neonatal outcomes (peripartum death, early neonatal death, or irreversible brain damage), the preventability of these traumatic complications for families is systematically called into question. Furthermore, recent data suggest that defining hypoxia profiles associated with tracing characteristics would allow for more accurate identification of these situations, and for improved use of intervention in a more appropriate manner in terms of time and resources, in an attempt to reduce the incidence of neonatal complications of hypoxic origin involved in the development of severe neurological sequelae.
- Conditions
- Neonatal Acidemia and Hypoxia
- Keywords
- Hypoxia Neonatal, Neonatal acidosis, Neonatal Acidemia, Obstetrical Surgery, Newborns
- Medical subject headings
- Hypoxia, Asphyxia Neonatorum
What is being measured
The primary outcome is the main question the study is designed to answer.
Apgar score
Apgar score:
- 7 to 10 points: Healthy baby
- 4 to 6 points: The baby needs some help (oxygen, stimulation, etc.)
- 0 to 3 points: Urgent situation; the baby needs immediate care
Measured: The score is measured 1 minute and 5 minutes after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start4 Apr 2025
- Primary completionAug 2026 (estimated)
- Study completion14 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Acidemia and HypoxiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333599
- Sponsor's protocol ID
- 9618
- Acronym
- RCFHypA
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00
- ClinicalTrials.gov ID
- NCT07333599
- Acronym / sponsor ID
- RCFHypA / 9618
- Conditions
- Neonatal Acidemia and Hypoxia
- Keywords
- Hypoxia Neonatal, Neonatal acidosis, Neonatal Acidemia, Obstetrical Surgery, Newborns
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- 14 Aug 2026 (estimated)
- First posted
- 12 Jan 2026 (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.
Severe neonatal acidosis is an identified risk factor for neonatal encephalopathies and severe neurological sequelae such as cerebral palsy. While intrapartum origin of such deterioration is rare (approximately 20% of adverse outcomes in term infants), screening for hypoxia that can lead to the development of severe acidosis remains inadequate. This results in both delays in diagnosis and/or intervention, and a parallel increase in obstetric interventions (cesarean sections and operative vaginal deliveries) sometimes performed with inappropriate indications, thus contributing to unnecessary maternal and neonatal comorbidities. Difficulties in analyzing fetal heart rate (FHR) patterns are identified as an independent risk factor, particularly due to significant inter- and intra-observer variability, in an examination that is nevertheless central to assessing fetal well-being during labor. An FHR analysis based on a thorough understanding of the physiology of fetal adaptation to hypoxia could allow for better recognition of situations where fetal compensation for hypoxic stress is no longer possible, when adaptive mechanisms are exhausted. Given that FHR interpretation errors are implicated in 35 to 50% of adverse neonatal outcomes (peripartum death, early neonatal death, or irreversible brain damage), the preventability of these traumatic complications for families is systematically called into question. Furthermore, recent data suggest that defining hypoxia profiles associated with tracing characteristics would allow for more accurate identification of these situations, and for improved use of intervention in a more appropriate manner in terms of time and resources, in an attempt to reduce the incidence of neonatal complications of hypoxic origin involved in the development of severe neurological sequelae.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Adult woman (≥ 18 years) with singleton pregnancy and cord arterial pH < 7.00
Key inclusion criteria (4 listed)
- Adult woman (≥ 18 years)
- Treated at Strasbourg University Hospital between January 1, 2014, and December 31, 2024
- Singleton pregnancy
- Cord arterial pH < 7.00
Key exclusion criteria (4 listed)
- Gestational age < 37 weeks
- Known congenital malformation
- Intrauterine fetal death diagnosed upon admission
- No cardiotocographic recording
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
Apgar score
Time frame: The score is measured 1 minute and 5 minutes after birth.
Apgar score: * 7 to 10 points: Healthy baby * 4 to 6 points: The baby needs some help (oxygen, stimulation, etc.) * 0 to 3 points: Urgent situation; the baby needs immediate care
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 12 Jan 2026.
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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.
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 Neonatal Acidemia and Hypoxia, run by University Hospital, Strasbourg, France 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 4 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 12 Jan 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 Georges-Emmanuel ROTH, Midwife (33.3.69.55.35.46, georges-emmanuel.roth@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apgar score (time frame: The score is measured 1 minute and 5 minutes after birth.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2026.