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

NCT ID: NCT05158881

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-10

Study Completion Date

2021-06-30

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.

Detailed Description

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Conditions

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Cerebral Oxygenation in Full-term Neonates

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neonates delivered by normal vaginal delivery

Near-infrared spectroscopy

Intervention Type 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.

Near-infrared spectroscopy

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.
Minimum Eligible Age

0 Minutes

Maximum Eligible Age

10 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marwa Mohamed Farag

OTHER

Sponsor Role lead

Responsible Party

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Marwa Mohamed Farag

Lecturer in Pediatrics, Faculty of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alaa IA Ibrahim, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Alexandria University, Egypt

Hesham A Ghazal, PhD

Role: STUDY_DIRECTOR

Faculty of Medicine, Alexandria University, Egypt

Marwa M Farag, PhD

Role: STUDY_CHAIR

Faculty of Medicine, Alexandria University, Egypt

Bahaa S Hammad

Role: STUDY_DIRECTOR

Faculty of Medicine, Alexandria University, Egypt

Locations

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

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0106540

Identifier Type: -

Identifier Source: org_study_id