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

Overview

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.

Full Title of Study: “Use of Near-infrared Spectroscopy in Cerebral Oxygenation Monitoring in Full Term Neonates During Transition After Birth”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: June 2, 2021

Interventions

• Device: Near-infrared spectroscopy
  • Near-infrared spectroscopy (NIRS) offers the non-invasive continuous monitoring of cerebral oxygenation and perfusion. Cerebral regional oxygen (crSO2) measured via NIRS represents a mixed tissue saturation value, thus enabling information on the balance of cerebral oxygen delivery and oxygen consumption.

Arms, Groups and Cohorts

• Neonates delivered by normal vaginal delivery
• Neonates delivered by elective cesarean section.

Clinical Trial Outcome Measures

Primary Measures

• 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 0 Minutes

Maximum Age: 10 Minutes

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Marwa Mohamed Farag
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Marwa Mohamed Farag, Lecturer in Pediatrics, Faculty of Medicine – Alexandria University
• Overall Official(s)
  • Alaa IA Ibrahim, MBBCh, Principal Investigator, Faculty of Medicine, Alexandria University, Egypt
  • Hesham A Ghazal, PhD, Study Director, Faculty of Medicine, Alexandria University, Egypt
  • Marwa M Farag, PhD, Study Chair, Faculty of Medicine, Alexandria University, Egypt
  • Bahaa S Hammad, Study Director, Faculty of Medicine, Alexandria University, Egypt