Asphyxia at Birth : Causes and Neonatal Outcome (ABC-NEO)
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|ClinicalTrials.gov Identifier: NCT03227536|
Recruitment Status : Completed
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||61448 participants|
|Official Title:||Asphyxia at Birth : Evolution of Birth Asphyxia Rate, Etiologies and Neonatal Outcome From 2000 to 2016|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227536
|Department of obstetrics, Femme Mère Enfant Hospital|
|Lyon, France, 69677|
|Principal Investigator:||Muriel DORET, Pr||Hospices Civils de Lyon|