Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05158881
Enrollment
60
Registered
2021-12-15
Start date
2021-01-10
Completion date
2021-06-30
Last updated
2021-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Oxygenation in Full-term Neonates

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.

Interventions

DEVICENear-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.

Sponsors

Marwa Mohamed Farag
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Minutes to 10 Minutes
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cerebral regional oxygen saturation monitoring (crSO2)the first 10 minutes of lifeMeasurements 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 lifeOxygen saturation was measured using pulse oximeter (Masimo or Nellcor) by applying a preductal pulseoximetry sensor to the right wrist.
Blood gas analysisup to 10 minutes of lifeIt 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 lifeAfter 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026