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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Preterm Birth
- Sponsor
- Medical University of Graz
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- HbF (g/dL)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
HbF (g/dL)
Time Frame: First two weeks after birth
Fetal hemoglobin concentration in g/dL
Change of cFTOE
Time Frame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
cerebral fractional tissue oxygen extraction (cFTOE)
FHbF (%)
Time Frame: First two weeks after birth
Fraction of fetal hemoglobin in percentage
Change of cTOI
Time Frame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
cerebral tissue oxygenation index (cTOI)
Change of pTOI
Time Frame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
peripheral tissue oxygenation index (pTOI)
Change of pFTOE
Time Frame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
peripheral fractional tissue oxygen extraction (pFTOE)