Fetal Haemoglobin and Cerebral and Peripheral Oxygenation. (HbFIN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Oxygen Toxicity; Fetal Hemoglobin
• Intervention / Treatment: Device: Near-infrared spectroscopy

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Gerhard Pichler, Prof; Phone Number: +43 316 385 80520; Email: gerhard.pichler@medunigraz.at
• Study Contact Backup: Name: Ena Pritisanac, MD; Phone Number: +43 316 385 80531; Email: ena.pritisanac@medunigraz.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Recruiting
      • Department of Pediatrics, Division of Neonatology, Medical University of Graz
      • Contact: Gerhard Pichler, MD; Phone Number: 0043 316 385 80520; Email: gerhard.pichler@medunigraz.at
      • Contact: Ena Pritisanac, MD; Phone Number: 0043 316 385 80531; Email: ena.pritisanac@medunigraz.at
      • Principal Investigator: Gerhard Pichler, Prof
      • Sub-Investigator: Ena Pritisanac, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 3 weeks (Child)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Term neonates; ≥ 37+0 weeks of gestation	Device: Near-infrared spectroscopy; For NIRS measurements the t-NIRS 1 and NIRO 200 NX (Hamamatsu, Japan) will be used. A cerebral sensor will be placed and fixed with a CPAP (Continuous Positive Airway Pressure) cap on the left forehead and a peripheral sensor on the right forearm. Duration of measurement will be two hours.
Preterm neonates; ≤ 36+6 weeks of gestation	Device: Near-infrared spectroscopy; For NIRS measurements the t-NIRS 1 and NIRO 200 NX (Hamamatsu, Japan) will be used. A cerebral sensor will be placed and fixed with a CPAP (Continuous Positive Airway Pressure) cap on the left forehead and a peripheral sensor on the right forearm. Duration of measurement will be two hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FHbF (%)	Fraction of fetal hemoglobin in percentage	First two weeks after birth
HbF (g/dL)	Fetal hemoglobin concentration in g/dL	First two weeks after birth
Change of cTOI	cerebral tissue oxygenation index (cTOI)	at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
Change of pTOI	peripheral tissue oxygenation index (pTOI)	at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
Change of cFTOE	cerebral fractional tissue oxygen extraction (cFTOE)	at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)
Change of pFTOE	peripheral fractional tissue oxygen extraction (pFTOE)	at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Gerhard Pichler, Prof, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: near-infrared spectroscopy; cerebral oxygenation; Fetal hemoglobin; preterm neonate; term neonate; peripheral oxygenation; fractional tissue oxygen extraction
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: HbF Version 1.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No