Fetal Haemoglobin and Cerebral and Peripheral Oxygenation.

Completed

• Conditions: Preterm Birth; Fetal Hemoglobin; Oxygen Toxicity
• Interventions: Device: Near-infrared spectroscopy

• Registration Number: NCT04802629
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2020-06-08
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Primary Completion: 2024-03-22
• Study Completion: 2024-03-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Term neonates	Near-infrared spectroscopy	≥ 37+0 weeks of gestation
Preterm neonates	Near-infrared spectroscopy	≤ 36+6 weeks of gestation

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Pediatrics, Division of Neonatology, Medical University of Graz; 🇦🇹 Graz, Styria, Austria