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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cerebral Oxygenation in Full-term Neonates

Intervention / Treatment
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* Device: Near-infrared spectroscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Minutes
Maximum Age: 10 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates delivered by normal vaginal delivery<br> | Device: Near-infrared spectroscopy<br>* 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.<br>|
| Neonates delivered by elective cesarean section.<br> | Device: Near-infrared spectroscopy<br>* 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.<br>|

What is the study measuring?
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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 |