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Eucapnic pH Compared With Arterial pH and Base Deficit

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03866876
Acronym
PHE
Enrollment
36435
Registered
2019-03-07
Start date
2018-09-01
Completion date
2019-04-30
Last updated
2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurologic Complication

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.

Interventions

OTHEREucapnic pH

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

Countries

France

Contacts

Primary ContactMuriel DORET, Prof.
muriel.doret-dion@chu-lyon.fr4 27 85 51 70

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026