Near-infrared Spectroscopy in Cerebral Oxygenation Monitoring in Full Term Neonates

Completed

• Conditions: Cerebral Oxygenation in Full-term Neonates
• Interventions: Device: Near-infrared spectroscopy

• Registration Number: NCT05158881
• Lead Sponsor: Marwa Mohamed Farag

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-10
• Primary Completion: 2021-06-02
• Study Completion: 2021-06-30
• Status Verified: 2021-12
• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Last Update Submitted: 2021-12-02
• Study First Posted: 2021-12-15
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neonates delivered by normal vaginal delivery	Near-infrared spectroscopy	-
Neonates delivered by elective cesarean section.	Near-infrared spectroscopy	-

Primary Outcome Measures

Name	Time	Method
Cerebral regional oxygen saturation monitoring (crSO2)	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)	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	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)	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

Trial Locations

Locations (1)

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.; 🇪🇬 Alexandria, Egypt