PHE: Eucapnic pH Compared With Arterial pH and Base Deficit

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Unknown status

CT.gov ID

NCT03866876

Collaborator

(none)

36,435

Enrollment

Location

Anticipated Duration (Months)

5231.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neurologic Complication	Other: Eucapnic pH

Study Design

Study Type:

Observational

Anticipated Enrollment :

36435 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Apr 1, 2019

Anticipated Study Completion Date :

Apr 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Hôpital Femme Mère Enfants births

Other: Eucapnic pH

Collection of Biological marker (proposed by Racinet): eucapnic pH

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Femme Mère Enfant	Bron		France	69500

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT03866876

Other Study ID Numbers:

First Posted:

Mar 7, 2019

Last Update Posted:

Mar 7, 2019

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 7, 2019