Asphyxia at Birth : Causes and Neonatal Outcome

Neonatal Asphyxia Clinical Trial

— ABC-NEO  

Official title:

Asphyxia at Birth : Evolution of Birth Asphyxia Rate, Etiologies and Neonatal Outcome From 2000 to 2016

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03227536
• Other study ID #: 17-118
• Status: Completed
• Phase: N/A
• First received: July 11, 2017
• Last updated: July 21, 2017
• Start date: January 2017
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61448
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Hour

Eligibility

Inclusion Criteria:

• All births at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2000 to 31 december 2016

Exclusion Criteria:

• Infants born after medical pregnancy termination and born out of the hospital and secondarily hospitalized in our department will be excluded

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Neonatal Asphyxia

Locations

Country	Name	City	State
France	Department of obstetrics, Femme Mère Enfant Hospital	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 months