Preterm Birth Clinical Trial
— HbFINOfficial 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
NCT number | NCT04802629 |
Other study ID # | HbF Version 1.3 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 8, 2020 |
Est. completion date | May 1, 2024 |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Austria | Department of Pediatrics, Division of Neonatology, Medical University of Graz | Graz | Styria |
Lead Sponsor | Collaborator |
---|---|
Medical University of Graz |
Austria,
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) |
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