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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04802629
Other study ID # HbF Version 1.3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 8, 2020
Est. completion date May 1, 2024

Study information

Verified date May 2023
Source Medical University of Graz
Contact Gerhard Pichler, Prof
Phone +43 316 385 80520
Email gerhard.pichler@medunigraz.at
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 neonates.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Days to 3 Weeks
Eligibility Inclusion Criteria: - Term and preterm neonates admitted to the neonatal intensive care unit (NICU) - Decision to conduct full life support - Written informed consent Exclusion Criteria: - No decision to conduct full life support - No written informed consent - Congenital malformations - Family history of haemoglobinopathies (e.g. sickle cell anaemia, thalassaemia)

Study Design


Intervention

Device:
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.

Locations

Country Name City State
Austria Department of Pediatrics, Division of Neonatology, Medical University of Graz Graz Styria

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary FHbF (%) Fraction of fetal hemoglobin in percentage First two weeks after birth
Primary HbF (g/dL) Fetal hemoglobin concentration in g/dL First two weeks after birth
Primary Change of cTOI cerebral tissue oxygenation index (cTOI) at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
Primary Change of pTOI peripheral tissue oxygenation index (pTOI) at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
Primary Change of cFTOE cerebral fractional tissue oxygen extraction (cFTOE) at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
Primary Change of pFTOE peripheral fractional tissue oxygen extraction (pFTOE) at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
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