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

NCT05158881 | Completed

• 1 other identifier: 0106540
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Oxygenation in Full-term Neonates

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Neonates delivered by normal vaginal delivery

Device: Near-infrared spectroscopy

Neonates delivered by elective cesarean section.

Device: Near-infrared spectroscopy

Interventions

Near-infrared spectroscopy DEVICE

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.; Neonates delivered by normal vaginal delivery

Eligibility Criteria

• Age: 0 Minutes - 10 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marwa Mohamed Farag: lead

Study Sites (1)

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Alexandria, 21131, Egypt

Location

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Alaa IA Ibrahim, MBBCh

  Faculty of Medicine, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Hesham A Ghazal, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY DIRECTOR

• Marwa M Farag, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY CHAIR

• Bahaa S Hammad

  Faculty of Medicine, Alexandria University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer in Pediatrics, Faculty of Medicine

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: January 10, 2021
• Primary Completion: June 2, 2021
• Study Completion: June 30, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

EG (1)