Fetal Haemoglobin and Cerebral and Peripheral Oxygenation. (HbFIN)

Medical University of Graz

Status: Completed

Conditions: Fetal Hemoglobin; Oxygen Toxicity; Preterm Birth

Treatments: Device: Near-infrared spectroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT04802629

HbF Version 1.3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 2 days to 3 weeks old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

50 participants in 2 patient groups

Term neonates

Description:

≥ 37+0 weeks of gestation

Treatment:

Device: Near-infrared spectroscopy

Preterm neonates

Description:

≤ 36+6 weeks of gestation

Treatment:

Device: Near-infrared spectroscopy