An observational study in Cerebral Oxygenation in Full-term Neonates, sponsored by Marwa Mohamed Farag. Completed at 1 site in Egypt. Open to participants aged 0 Minutes to 10 Minutes, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-15.
Sponsored by Marwa Mohamed Farag · Observational
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.
Marwa Mohamed Farag is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Full term neonates born either via normal vaginal delivery or elective cesarean section.
Exclusion Criteria:
Device: Near-infrared spectroscopy
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: up to 10 minutes of life
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Marwa Mohamed Farag