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

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Oxygenation in Full-term Neonates
• Intervention / Treatment: Device: Near-infrared spectroscopy

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21131
    • Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 10 minutes (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Full term neonates born either via normal vaginal delivery or elective cesarean section.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neonates delivered by normal vaginal delivery	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.
Neonates delivered by elective cesarean section.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral regional oxygen saturation monitoring (crSO2)	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.	the first 10 minutes of life
Peripheral oxygen saturation monitoring (SpO2)	Oxygen saturation was measured using pulse oximeter (Masimo or Nellcor) by applying a preductal pulseoximetry sensor to the right wrist.	the first 10 minutes of life
Blood gas analysis	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.	up to 10 minutes of life
Fractional tissue oxygen extraction (FTOE)	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	up to 10 minutes of life

Collaborators and Investigators

• Sponsor: Marwa Mohamed Farag
• Investigators: Principal Investigator: Alaa IA Ibrahim, MBBCh, Faculty of Medicine, Alexandria University, Egypt; Study Director: Hesham A Ghazal, PhD, Faculty of Medicine, Alexandria University, Egypt; Study Director: Bahaa S Hammad, Faculty of Medicine, Alexandria University, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2021
• Primary Completion (ACTUAL): June 2, 2021
• Study Completion (ACTUAL): June 30, 2021

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (ACTUAL): December 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 0106540

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No