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Fetal Haemoglobin and Cerebral and Peripheral Oxygenation.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04802629
Acronym
HbFIN
Enrollment
50
Registered
2021-03-17
Start date
2020-06-08
Completion date
2024-03-22
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Hemoglobin, Oxygen Toxicity, Preterm Birth

Keywords

Fetal hemoglobin, preterm neonate, term neonate, near-infrared spectroscopy, cerebral oxygenation, peripheral oxygenation, fractional tissue oxygen extraction

Brief 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.

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.

Interventions

DEVICENear-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.

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Days to 3 Weeks
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
FHbF (%)First two weeks after birthFraction of fetal hemoglobin in percentage
HbF (g/dL)First two weeks after birthFetal hemoglobin concentration in g/dL
Change of cTOIat specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)cerebral tissue oxygenation index (cTOI)
Change of pTOIat specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)peripheral tissue oxygenation index (pTOI)
Change of cFTOEat specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)cerebral fractional tissue oxygen extraction (cFTOE)
Change of pFTOEat specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)peripheral fractional tissue oxygen extraction (pFTOE)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026