HbFIN: Fetal Haemoglobin and Cerebral and Peripheral Oxygenation.

Sponsor

Medical University of Graz (Other)

Overall Status

Recruiting

CT.gov ID

NCT04802629

Collaborator

(none)

Enrollment

Location

24.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth Oxygen Toxicity Fetal Hemoglobin	Device: Near-infrared spectroscopy

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Observational Model:

Other

Time Perspective:

Prospective

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

Actual Study Start Date :

Jun 8, 2020

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Term neonates ≥ 37+0 weeks of gestation	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.
Preterm neonates ≤ 36+6 weeks of gestation	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.

Arm

Intervention/Treatment

Term neonates

≥ 37+0 weeks of gestation

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.

Preterm neonates

≤ 36+6 weeks of gestation

Device: Near-infrared spectroscopy

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Days to 3 Weeks

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pediatrics, Division of Neonatology, Medical University of Graz	Graz	Styria	Austria	8036

Sponsors and Collaborators

Medical University of Graz

Investigators

Principal Investigator: Gerhard Pichler, Prof, Medical University of Graz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Graz

ClinicalTrials.gov Identifier:

NCT04802629

Other Study ID Numbers:

HbF Version 1.3

First Posted:

Mar 17, 2021

Last Update Posted:

Mar 24, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Medical University of Graz

Fetal hemoglobin

preterm neonate

term neonate

near-infrared spectroscopy

cerebral oxygenation

peripheral oxygenation

fractional tissue oxygen extraction

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Mar 24, 2022