Asphyxia at Birth : Causes and Neonatal Outcome

NCT03227536 | Completed

• 1 other identifier: 17-118
• Study Type: observational
• Target: 61,448
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Asphyxia

Keywords

Neonatal asphyxia; neonatal acidosis; fetal ECG; umbilical cord acid-base status

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: Up to 1 Hour
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Department of obstetrics, Femme Mère Enfant Hospital

Lyon, 69677, France

Location

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Muriel DORET, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 24, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

FR (1)