Cerebral Oxygenation in Full-term NeonatesNCT05158881
Near-infrared Spectroscopy in Cerebral Oxygenation Monitoring in Full Term Neonates
An observational study of Cerebral Oxygenation in Full-term Neonates, run by Marwa Mohamed Farag at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 10 minutesHealthy volunteers can take part
- Conditions the study is for
- Cerebral Oxygenation in Full-term Neonates
- What is being tested?
- Near-infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2021to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 10 minutes
- All sexes
- Healthy volunteers accepted
- Child
Study population: Full term neonates born either via normal vaginal delivery or elective cesarean section.
Who may be able to join
- Gestational age ≥38 weeks, without any medical support and normal pregnancy development.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Alexandria, 21131
About this study
Official title: Use of Near-infrared Spectroscopy in Cerebral Oxygenation Monitoring in Full Term Neonates During Transition After Birth
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.
- Being tested
- Near-infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Neonates delivered by normal vaginal delivery | Not described Receives: Device: Near-infrared spectroscopy | |
| Neonates delivered by elective cesarean section. | Not described Receives: Device: Near-infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: up to 10 minutes of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start10 Jan 2021
- Primary completion2 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Oxygenation in Full-term NeonatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marwa Mohamed Farag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marwa Mohamed Farag, Alexandria University
- Investigators
- Alaa IA Ibrahim, MBBCh, Principal investigator, Faculty of Medicine, Alexandria University, EgyptHesham A Ghazal, PhD, Study director, Faculty of Medicine, Alexandria University, EgyptMarwa M Farag, PhD, Study chair, Faculty of Medicine, Alexandria University, EgyptBahaa S Hammad, Study director, Faculty of Medicine, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158881
- Sponsor's protocol ID
- 0106540
- Status last verified
- Dec 2021
- First submitted
- 2 Dec 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Near-infrared Spectroscopy in Cerebral Oxygenation Monitoring in Full Term Neonates During Transition After Birth
- ClinicalTrials.gov ID
- NCT05158881
- Acronym / sponsor ID
- 0106540
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marwa Mohamed FaragUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonates delivered by normal vaginal delivery | – | Device: Near-infrared spectroscopy |
| Neonates delivered by elective cesarean section. | – | Device: Near-infrared spectroscopy |
Who may qualify
- Ages
- 0 to 10 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Full term neonates born either via normal vaginal delivery or elective cesarean section.
Key inclusion criteria (1 listed)
- Gestational age ≥38 weeks, without any medical support and normal pregnancy development.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near-infrared spectroscopyNear-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. | Device | Neonates delivered by elective cesarean section., Neonates delivered by normal vaginal delivery |
Primary outcome
Cerebral regional oxygen saturation monitoring (crSO2)
Time frame: the first 10 minutes of life
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.
Peripheral oxygen saturation monitoring (SpO2)
Time frame: the first 10 minutes of life
Oxygen saturation was measured using pulse oximeter (Masimo or Nellcor) by applying a preductal pulseoximetry sensor to the right wrist.
Blood gas analysis
Time frame: up to 10 minutes of life
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.
Fractional tissue oxygen extraction (FTOE)
Time frame: up to 10 minutes of life
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa IA Ibrahim, MBBCh principal investigator
Faculty of Medicine, Alexandria University, Egypt
Hesham A Ghazal, PhD study director
Faculty of Medicine, Alexandria University, Egypt
Marwa M Farag, PhD study chair
Faculty of Medicine, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Oxygenation in Full-term Neonates, run by Marwa Mohamed Farag at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral regional oxygen saturation monitoring (crSO2) (time frame: the first 10 minutes of life). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.