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Completed

NCT Number: NCT04802629

Fetal Haemoglobin and Cerebral and Peripheral Oxygenation.

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.

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Key information

Conditions

Preterm Birth Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Hemoglobin Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Obstetric Labor Complications Obstetric Labor, Premature Oxygen Toxicity Pregnancy Complications Premature Birth Thalassemia Urogenital Diseases beta-Thalassemia

Age range

2 day–3 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatrics, Division of Neonatology, Medical University of Graz

Graz, Styria, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Near-infrared spectroscopy

Device

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.

Primary outcomes

  1. FHbF (%)

    Time frame: First two weeks after birth

    Fraction of fetal hemoglobin in percentage

  2. HbF (g/dL)

    Time frame: First two weeks after birth

    Fetal hemoglobin concentration in g/dL

  3. Change of cTOI

    Time frame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)

    cerebral tissue oxygenation index (cTOI)

  4. Change of pTOI

    Time frame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)

    peripheral tissue oxygenation index (pTOI)

  5. Change of cFTOE

    Time frame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)

    cerebral fractional tissue oxygen extraction (cFTOE)

  6. Change of pFTOE

    Time frame: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)

    peripheral fractional tissue oxygen extraction (pFTOE)

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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

Acronym: HbFIN

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 17, 2021
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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