Eucapnic pH Compared With Arterial pH and Base Deficit (PHE)

Umbilical Cord Arterial Eucapnic pH Compared With Arterial pH and Base Deficit as Predictor of Severe Adverse Outcomes Among Term Neonates

Neonatal asphyxia per partum can be complicated by severe neurologic sequelae and can lead to neonatal death. Of the 0.2% of live births to cerebral palsy, 10 to 28% would be secondary to neonatal acidosis. Only metabolic acidosis plays a neurotoxic role, explaining the recent interest of Racinet et al. in the development of a new biochemical marker, more specific than pH or base deficit, of neonatal asphyxia per partum at risk of anoxo-ischemic encephalopathy. This eucapnic neonatal pH raises the hope of a biochemical marker of situations at risk of poor prognosis, with high diagnostic value, prognostic and forensic.

Our hypothesis is that eucapnic pH is more efficient than cord blood arterial pH and base deficit in the prediction of adverse neurologic outcomes.

Study Overview

• Status: Unknown
• Conditions: Neurologic Complication
• Intervention / Treatment: Other: Eucapnic pH

• Study Type: Observational
• Enrollment (Anticipated): 36435

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Hopital Femme Mere Enfant
    • Contact: Muriel DORET, Prof.
    • Principal Investigator: Muriel DORET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All birth more than 37 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2000 to 31 december 2016

Description

Inclusion Criteria:

• All birth more than 37 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant
• from 1st of january 2000 to 31 december 2016

Exclusion Criteria:

• Infants born out of the hospital and secondarily hospitalized in the hospital Femme-Mère-Enfant
• Children with congenital anomalies or without valid arterial and venous umbilical cord samples

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hôpital Femme Mère Enfants births	Other: Eucapnic pH; Collection of Biological marker (proposed by Racinet): eucapnic pH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with at least one of these criteria including neonatal seizure, neonatal hypotonia requiring intensive care unit admission, neonatal encephalopathy, and/or neonatal death.	Between 2000 and 2016

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Muriel DORET, Prof., Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PHE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No