Eucapnic pH Compared With Arterial pH and Base Deficit

Neurologic Complication Clinical Trial

— PHE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03866876
• Other study ID #: PHE
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: April 2019

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: Muriel DORET, Prof.
• Phone: 4 27 85 51 70
• Email: muriel.doret-dion[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36435
• Est. completion date: April 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neurologic Complication

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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