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Clinical Trials/NCT05158881
NCT05158881
Completed
Not Applicable

Use of Near-infrared Spectroscopy in Cerebral Oxygenation Monitoring in Full Term Neonates During Transition After Birth

Marwa Mohamed Farag1 site in 1 country60 target enrollmentJanuary 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Oxygenation in Full-term Neonates
Sponsor
Marwa Mohamed Farag
Enrollment
60
Locations
1
Primary Endpoint
Cerebral regional oxygen saturation monitoring (crSO2)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aim of the study was to assess the values of cerebral oxygenation in full-term neonates in the first 10 minutes of life and to compare these values between neonates delivered by normal vaginal delivery and those delivered by elective cesarean section.

Registry
clinicaltrials.gov
Start Date
January 10, 2021
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Marwa Mohamed Farag
Responsible Party
Sponsor Investigator
Principal Investigator

Marwa Mohamed Farag

Lecturer in Pediatrics, Faculty of Medicine

Alexandria University

Eligibility Criteria

Inclusion Criteria

  • Gestational age ≥38 weeks, without any medical support and normal pregnancy development.

Exclusion Criteria

  • Newborns with gestational age \<38 weeks.
  • Newborns with intrauterine growth restriction.
  • Evidence of perinatal depression (hypoxic ischemic encephalopathy).
  • The need for respiratory support or oxygen therapy in the first 10 minutes of life.
  • Suspected or known brain malformations or congenital cyanotic heart disease.
  • Birth complications (e.g. vacuum extraction or forceps application).
  • Newborn delivered through cesarean section with previous attempts of normal vaginal delivery.

Outcomes

Primary Outcomes

Cerebral regional oxygen saturation monitoring (crSO2)

Time Frame: the first 10 minutes of life

Measurements was done by using Near infrared spectroscopy (INVOSTM 5100C Cerebral/ Somatic Oximeter Monitor; Covidien) by placing a neonatal brain sensor on the left frontoparietal area of the newborn's head.

Peripheral oxygen saturation monitoring (SpO2)

Time Frame: the first 10 minutes of life

Oxygen saturation was measured using pulse oximeter (Masimo or Nellcor) by applying a preductal pulseoximetry sensor to the right wrist.

Blood gas analysis

Time Frame: up to 10 minutes of life

It was performed from umbilical cord blood. All newborns will be clinically observed and evaluated during this period by a neonatologist, and clinical status will be assessed by Apgar score. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.

Fractional tissue oxygen extraction (FTOE)

Time Frame: up to 10 minutes of life

After measuring peripheral oxygen saturation (SpO2) and cerebral regional oxygen saturation (crSO2). For evaluation of the balance of oxygen delivery and oxygen consumption, calculation of the fractional tissue oxygen extraction can be done using the following equation: FTOE=(SpO2-crSO2)/SpO2

Study Sites (1)

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