Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04802629
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2021-03-15
Brief Title:
Fetal Haemoglobin and Cerebral and Peripheral Oxygenation
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HbFIN
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None