Fetal Haemoglobin and Cerebral and Peripheral Oxygenation.
NCT ID: NCT04802629
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
50 participants
OBSERVATIONAL
2020-06-08
2024-03-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates
NCT04818762
Cerebral Oxygenation in Preterm Neonates with Respiratory Support During Skin-to-skin Care on the First Day After Birth
NCT04865302
Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants
NCT01255189
Cerebral Tissue Oxygenation in Very Low Birthweight Infants in the First 3 Days of Life
NCT01430728
Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates
NCT04538079
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Term neonates
≥ 37+0 weeks of gestation
Near-infrared spectroscopy
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.
Preterm neonates
≤ 36+6 weeks of gestation
Near-infrared spectroscopy
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Near-infrared spectroscopy
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Decision to conduct full life support
* Written informed consent
Exclusion Criteria
* No written informed consent
* Congenital malformations
* Family history of haemoglobinopathies (e.g. sickle cell anaemia, thalassaemia)
2 Days
3 Weeks
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Graz
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gerhard Pichler, Prof
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Pediatrics, Division of Neonatology, Medical University of Graz
Graz, Styria, Austria
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HbF Version 1.3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.