Clinical trial NCT04802629: Fetal Haemoglobin and Cerebral and Peripheral Oxygenation.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Oxygen Toxicity
Fetal Hemoglobin
Keywords: Fetal hemoglobin
preterm neonate
term neonate
near-infrared spectroscopy
cerebral oxygenation
peripheral oxygenation
fractional tissue oxygen extraction
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm neonates (≤ 36+6 weeks of gestation) and term neonates (≥ 37+0 weeks of gestation) admitted to the NICU.

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.

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)

Primary outcomes:
measure: FHbF (%)
timeFrame: First two weeks after birth
measure: HbF (g/dL)
timeFrame: First two weeks after birth
measure: Change of cTOI
timeFrame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
measure: Change of pTOI
timeFrame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
measure: Change of cFTOE
timeFrame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
measure: Change of pFTOE
timeFrame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Pediatrics, Division of Neonatology, Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Gerhard Pichler, Prof
role: PRINCIPAL_INVESTIGATOR
References: