Neonatal AsphyxiaABC-NEONCT03227536
Asphyxia at Birth : Causes and Neonatal Outcome
An observational study of Neonatal Asphyxia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This is an historic cohort study based on the birth and delivery register of the HFME maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all gestational ages, identifying causes and describing neonatal outcomes since 2000, when a second line strategy for foetal surveillance (fetal… Read more about this study
- Who is it for?
- Ages Up to 1 hour
- Conditions the study is for
- Neonatal Asphyxia
- How many people
- 61,448 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 hour
- All sexes
- No healthy volunteers
- Child
Study population: All births at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2000 to 31 december 2016
Who may be able to join
- All births at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2000 to 31 december 2016
Who cannot join
- Infants born after medical pregnancy termination and born out of the hospital and secondarily hospitalized in our department will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Asphyxia at Birth : Evolution of Birth Asphyxia Rate, Etiologies and Neonatal Outcome From 2000 to 2016
This is an historic cohort study based on the birth and delivery register of the HFME maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all gestational ages, identifying causes and describing neonatal outcomes since 2000, when a second line strategy for foetal surveillance (fetal ECG) and systematic umbilical acid-gas cord blood were introduced in our maternity ward.
The investigator's hypothesis was that the neonatal asphyxia decrease could be due to 3 main factors including second line strategy introduction, systematic umbilical cord acid-base implementation and improvement in antenatal risk factor screening for asphyxia. The investigator's second hypothesis was that neonatal prognosis in neonates with acidosis was improved with systematic early after birth EEG evaluation, allowing early treatment and surveillance.
- Conditions
- Neonatal Asphyxia
- Keywords
- Neonatal asphyxia, neonatal acidosis, fetal ECG, umbilical cord acid-base status
- Medical subject headings
- Asphyxia Neonatorum
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Neonatal asphyxia
Neonatal asphyxia define as fetal death, neonatal death, NICU transfer, neonatal seizure, umbilical-artery blood pH ≤ 7.05 with a base deficit ≥ 12 mmol per liter, intubation for ventilation at delivery or neonatal encephalopathy
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study startJan 2017
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal AsphyxiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 61,448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muriel DORET, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227536
- Sponsor's protocol ID
- 17-118
- Acronym
- ABC-NEO
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asphyxia at Birth : Evolution of Birth Asphyxia Rate, Etiologies and Neonatal Outcome From 2000 to 2016
- ClinicalTrials.gov ID
- NCT03227536
- Acronym / sponsor ID
- ABC-NEO / 17-118
- Conditions
- Neonatal Asphyxia
- Keywords
- Neonatal asphyxia, neonatal acidosis, fetal ECG, umbilical cord acid-base status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61,448 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 24 Jul 2017 (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.
This is an historic cohort study based on the birth and delivery register of the HFME maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all gestational ages, identifying causes and describing neonatal outcomes since 2000, when a second line strategy for foetal surveillance (fetal ECG) and systematic umbilical acid-gas cord blood were introduced in our maternity ward.
The investigator's hypothesis was that the neonatal asphyxia decrease could be due to 3 main factors including second line strategy introduction, systematic umbilical cord acid-base implementation and improvement in antenatal risk factor screening for asphyxia. The investigator's second hypothesis was that neonatal prognosis in neonates with acidosis was improved with systematic early after birth EEG evaluation, allowing early treatment and surveillance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 1 hour
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All births at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2000 to 31 december 2016
Key inclusion criteria (1 listed)
- All births at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2000 to 31 december 2016
Key exclusion criteria (1 listed)
- Infants born after medical pregnancy termination and born out of the hospital and secondarily hospitalized in our department will be excluded
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
Rate of Neonatal asphyxia
Time frame: 2 months
Neonatal asphyxia define as fetal death, neonatal death, NICU transfer, neonatal seizure, umbilical-artery blood pH ≤ 7.05 with a base deficit ≥ 12 mmol per liter, intubation for ventilation at delivery or neonatal encephalopathy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
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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. This study is not recruiting at the moment.
Muriel DORET, Pr principal investigator
Hospices Civils de Lyon
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 Asphyxia, run by Hospices Civils de Lyon 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jul 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Neonatal asphyxia (time frame: 2 months). 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 24 Jul 2017.