Neonatal AdaptationCOINNCT04594824
Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth
An observational study of Neonatal Adaptation, run by Medical University of Graz at 1 site in Austria.
Trial summary
Especially in neonates non-invasive methods are required for monitoring the complex changes during immediate transition after birth to improve assessment of neonate and eventually resuscitation. Read more about this study
- Who is it for?
- Ages 0 to 15 minutesHealthy volunteers can take part
- Conditions the study is for
- Neonatal Adaptation
- How many people
- 192 participants
- Where
- 1 siteAustria
- Study dates
- 13 Nov 2020to 4 Apr 2022
- 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 15 minutes
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates immediatley after birth
Who may be able to join
- Term and preterm neonates observed routinely at the resuscitation desk
- Decision to conduct full life support
- Written informed consent
- Neonates who require no respiratory or medical support
Who cannot join
- No decision to conduct full life Support
- No written informed consent
- Congenital malformation
- Neonates who require respiratory and/ or medical support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth - a Prospective Observational Study
Especially in neonates non-invasive methods are required for monitoring the complex changes during immediate transition after birth to improve assessment of neonate and eventually resuscitation. During this period especially, the brain is vulnerable and monitoring the brain and possible influencing factors of cerebral oxygenation and perfusion are of great interest. To initiate and guide therapies based on cerebral oxygenation, it is important to define reference ranges.
- Conditions
- Neonatal Adaptation
- Being tested
- No Intervention
- Keywords
- percentile, cerebral oxygenation, neonate, immediate after birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Term neonates | Not described Receives: Other: No Intervention | |
| Preterm neonates | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cerebral tissue oxygen saturation (crSO2) level
To measure cerebral oxygenation with Root (O3 regional oxymetry, Masimo, USA) non-invasively and continuously during the first 15 minutes after birth and establish the reference ranges in term and preterm neonates.
Measured: At each minute from minute 1 to minute 15 after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start13 Nov 2020
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal AdaptationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594824
- Sponsor's protocol ID
- 32-320 ex 19/2
- Acronym
- COIN
- Status last verified
- May 2023
- First submitted
- 16 Oct 2020
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04594824
- Acronym / sponsor ID
- COIN / 32-320 ex 19/2
- Conditions
- Neonatal Adaptation
- Keywords
- percentile, cerebral oxygenation, neonate, immediate after birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 20 Oct 2020 (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.
Especially in neonates non-invasive methods are required for monitoring the complex changes during immediate transition after birth to improve assessment of neonate and eventually resuscitation. During this period especially, the brain is vulnerable and monitoring the brain and possible influencing factors of cerebral oxygenation and perfusion are of great interest. To initiate and guide therapies based on cerebral oxygenation, it is important to define reference ranges.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Term neonates | – | Other: No Intervention |
| Preterm neonates | – | Other: No Intervention |
Who may qualify
- Ages
- 0 to 15 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates immediatley after birth
Key inclusion criteria (4 listed)
- Term and preterm neonates observed routinely at the resuscitation desk
- Decision to conduct full life support
- Written informed consent
- Neonates who require no respiratory or medical support
Key exclusion criteria (4 listed)
- No decision to conduct full life Support
- No written informed consent
- Congenital malformation
- Neonates who require respiratory and/ or medical support
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 |
|---|---|---|
| No Interventionno intervention | Other | Preterm neonates, Term neonates |
Primary outcome
Change of cerebral tissue oxygen saturation (crSO2) level
Time frame: At each minute from minute 1 to minute 15 after birth
To measure cerebral oxygenation with Root (O3 regional oxymetry, Masimo, USA) non-invasively and continuously during the first 15 minutes after birth and establish the reference ranges in term and preterm neonates.
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 31 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neonatal Adaptation, run by Medical University of Graz at 1 site in Austria.
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 4 inclusion and 4 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 31 May 2023. 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 Austria. 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?
Change of cerebral tissue oxygen saturation (crSO2) level (time frame: At each minute from minute 1 to minute 15 after birth). 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 31 May 2023.