Preterm BirthHbFINNCT04802629
Fetal Haemoglobin and Cerebral and Peripheral Oxygenation.
An observational study of Preterm Birth and Oxygen Toxicity, run by Medical University of Graz at 1 site in Austria.
Trial summary
The aim of this study is to investigate the relationship between cerebral and peripheral oxygenation and oxygen extraction, as measured by NIRS (near-infrared spectroscopy ), and the FHbF (fraction of fetal hemoglobin) and absolute HbF (fetal hemoglobin) concentration in postnatal conditions in term and preterm… Read more about this study
- Who is it for?
- Ages 2 days to 3 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Oxygen Toxicity, Fetal Hemoglobin
- What is being tested?
- Near-infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 8 Jun 2020to 22 Mar 2024
- How long will I take part?
- 3 Weeks
- 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 2 days to 3 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm neonates (≤ 36+6 weeks of gestation) and term neonates (≥ 37+0 weeks of gestation) admitted to the NICU.
Who may be able to join
- Term and preterm neonates admitted to the neonatal intensive care unit (NICU)
- Decision to conduct full life support
- Written informed consent
Who cannot join
- No decision to conduct full life support
- No written informed consent
- Congenital malformations
- Family history of haemoglobinopathies (e.g. sickle cell anaemia, thalassaemia)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Pediatrics, Division of Neonatology, Medical University of Graz
Graz, Styria, 8036
About this study
Official title: Influence of Fetal Haemoglobin on Cerebral and Peripheral Oxygenation in Term and Preterm Neonates During the First Two Weeks After Birth Measured by Near Infrared Spectroscopy- a Prospective Observational Pilot Study
The aim of this study is to investigate the relationship between cerebral and peripheral oxygenation and oxygen extraction, as measured by NIRS (near-infrared spectroscopy ), and the FHbF (fraction of fetal hemoglobin) and absolute HbF (fetal hemoglobin) concentration in postnatal conditions in term and preterm neonates.
Read the detailed description
During gestation the main fetal oxygen carrier is fetal hemoglobin (HbF). HbF exhibits a significantly higher affinity for oxygen when compared to adult hemoglobin (HbA), which makes it more suitable for oxygen extraction at the lower partial oxygen pressures in utero. Although the regulation of HbF expression is determined developmentally, recent studies report a respectable variation in the fraction of HbF in neonates.
Such data suggest that the differences in HbF expression could affect end-tissue oxygenation in neonates.
The methodology for measuring oxygen saturation and extraction in cerebral and peripheral tissues of neonates using the near-infrared spectroscopy (NIRS) has been well practiced in our study group. However, the method has not yet been used to investigate whether the fraction of fetal hemoglobin (FHbF) plays a significant role in cerebral and peripheral oxygenation in neonates.
The aim of this study is to investigate the relationship between cerebral and peripheral oxygenation and oxygen extraction, as measured by NIRS, and the FHbF and absolute HbF concentration in postnatal conditions in term and preterm neonates.
- Conditions
- Preterm Birth, Oxygen Toxicity, Fetal Hemoglobin
- Being tested
- Near-infrared spectroscopy
- Keywords
- Fetal hemoglobin, preterm neonate, term neonate, near-infrared spectroscopy, cerebral oxygenation, peripheral oxygenation, fractional tissue oxygen extraction
- Medical subject headings
- Premature Birth, beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopyDevice
For NIRS measurements the t-NIRS 1 and NIRO 200 NX (Hamamatsu, Japan) will be used. A cerebral sensor will be placed and fixed with a CPAP (Continuous Positive Airway Pressure) cap on the left forehead and a peripheral sensor on the right forearm. Duration of measurement will be two hours.
| Study group | Role | What they receive |
|---|---|---|
| Term neonates | ≥ 37+0 weeks of gestation Receives: Device: Near-infrared spectroscopy | |
| Preterm neonates | ≤ 36+6 weeks of gestation Receives: Device: Near-infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
FHbF (%)
Fraction of fetal hemoglobin in percentage
Measured: First two weeks after birth
HbF (g/dL)
Fetal hemoglobin concentration in g/dL
Measured: First two weeks after birth
Change of cTOI
cerebral tissue oxygenation index (cTOI)
Measured: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
Change of pTOI
peripheral tissue oxygenation index (pTOI)
Measured: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
Change of cFTOE
cerebral fractional tissue oxygen extraction (cFTOE)
Measured: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
Change of pFTOE
peripheral fractional tissue oxygen extraction (pFTOE)
Measured: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start8 Jun 2020
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerhard Pichler, Prof, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802629
- Sponsor's protocol ID
- HbF Version 1.3
- Acronym
- HbFIN
- Status last verified
- Jul 2024
- First submitted
- 15 Mar 2021
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Fetal Haemoglobin on Cerebral and Peripheral Oxygenation in Term and Preterm Neonates During the First Two Weeks After Birth Measured by Near Infrared Spectroscopy- a Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT04802629
- Acronym / sponsor ID
- HbFIN / HbF Version 1.3
- Conditions
- Preterm Birth, Oxygen Toxicity, Fetal Hemoglobin
- Keywords
- Fetal hemoglobin, preterm neonate, term neonate, near-infrared spectroscopy, cerebral oxygenation, peripheral oxygenation, fractional tissue oxygen extraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 17 Mar 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 this study is to investigate the relationship between cerebral and peripheral oxygenation and oxygen extraction, as measured by NIRS (near-infrared spectroscopy ), and the FHbF (fraction of fetal hemoglobin) and absolute HbF (fetal hemoglobin) concentration in postnatal conditions in term and preterm neonates.
Detailed description
During gestation the main fetal oxygen carrier is fetal hemoglobin (HbF). HbF exhibits a significantly higher affinity for oxygen when compared to adult hemoglobin (HbA), which makes it more suitable for oxygen extraction at the lower partial oxygen pressures in utero. Although the regulation of HbF expression is determined developmentally, recent studies report a respectable variation in the fraction of HbF in neonates.
Such data suggest that the differences in HbF expression could affect end-tissue oxygenation in neonates.
The methodology for measuring oxygen saturation and extraction in cerebral and peripheral tissues of neonates using the near-infrared spectroscopy (NIRS) has been well practiced in our study group. However, the method has not yet been used to investigate whether the fraction of fetal hemoglobin (FHbF) plays a significant role in cerebral and peripheral oxygenation in neonates.
The aim of this study is to investigate the relationship between cerebral and peripheral oxygenation and oxygen extraction, as measured by NIRS, and the FHbF and absolute HbF concentration in postnatal conditions in term and preterm neonates.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Term neonates | – | Device: Near-infrared spectroscopy≥ 37+0 weeks of gestation |
| Preterm neonates | – | Device: Near-infrared spectroscopy≤ 36+6 weeks of gestation |
Who may qualify
- Ages
- 2 days to 3 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm neonates (≤ 36+6 weeks of gestation) and term neonates (≥ 37+0 weeks of gestation) admitted to the NICU.
Key inclusion criteria (3 listed)
- Term and preterm neonates admitted to the neonatal intensive care unit (NICU)
- Decision to conduct full life support
- Written informed consent
Key exclusion criteria (4 listed)
- No decision to conduct full life support
- No written informed consent
- Congenital malformations
- Family history of haemoglobinopathies (e.g. sickle cell anaemia, thalassaemia)
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 spectroscopyFor NIRS measurements the t-NIRS 1 and NIRO 200 NX (Hamamatsu, Japan) will be used. A cerebral sensor will be placed and fixed with a CPAP (Continuous Positive Airway Pressure) cap on the left forehead and a peripheral sensor on the right forearm. Duration of measurement will be two hours. | Device | Preterm neonates, Term neonates |
Primary outcome
FHbF (%)
Time frame: First two weeks after birth
Fraction of fetal hemoglobin in percentage
HbF (g/dL)
Time frame: First two weeks after birth
Fetal hemoglobin concentration in g/dL
Change of cTOI
Time frame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
cerebral tissue oxygenation index (cTOI)
Change of pTOI
Time frame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
peripheral tissue oxygenation index (pTOI)
Change of cFTOE
Time frame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
cerebral fractional tissue oxygen extraction (cFTOE)
Change of pFTOE
Time frame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
peripheral fractional tissue oxygen extraction (pFTOE)
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 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Preterm Birth
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
Active, not recruiting
Serial Brain MRI in Hospitalized Preterm Infants
Preterm Birth Complication
RecruitingObservational study
Cervical Stiffness in Women With Threatened Preterm Labor
Preterm Labor, Preterm Birth
Not yet recruiting
Efficacy of a Video-based, Parent-centered Home Developmental Intervention for Infants at High Risk for Developmental Delay: a Multicenter Randomized Controlled Trial
Preterm
Recruiting
Music Intervention for Preterm Birth
Preterm Birth
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.
Gerhard Pichler, Prof principal investigator
Medical University of Graz
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 Preterm Birth and Oxygen Toxicity, 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 3 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 3 Jul 2024. 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?
FHbF (%) (time frame: First two weeks after birth). The study lists 6 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 3 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.