Eucapnic pH Compared With Arterial pH and Base Deficit

NCT03866876 | Unknown

• 1 other identifier: PHE
• Study Type: observational
• Target: 36,435
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurologic Complication

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Hôpital Femme Mère Enfants births

Other: Eucapnic pH

Interventions

Eucapnic pH OTHER

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

Hôpital Femme Mère Enfants births

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, 69500, France

RECRUITING

Study Officials

• Muriel DORET, Prof.

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muriel DORET, Prof.

CONTACT

4 27 85 51 70; muriel.doret-dion@chu-lyon.fr

Study Design

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

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 7, 2019
• Study Start: September 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

FR (1)