Fetal Haemoglobin and Cerebral and Peripheral Oxygenation.

Preterm Birth Clinical Trial

— HbFIN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04802629
• Other study ID #: HbF Version 1.3
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Fetal Hemoglobin
• Oxygen Toxicity
• Premature Birth
• Preterm Birth

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)