Fetal Haemoglobin and Cerebral and Peripheral Oxygenation.

NCT04802629 | Completed DMC

• 1 other identifier: HbF Version 1.3
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (2)

Term neonates

≥ 37+0 weeks of gestation

Device: Near-infrared spectroscopy

Preterm neonates

≤ 36+6 weeks of gestation

Device: Near-infrared spectroscopy

Interventions

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.

Preterm neonates; Term neonates

Eligibility Criteria

• Age: 2 Days - 3 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Term and preterm neonates admitted to the neonatal intensive care unit (NICU)
• Decision to conduct full life support
• Written informed consent

You may not qualify if:

• No decision to conduct full life support
• No written informed consent
• Congenital malformations
• Family history of haemoglobinopathies (e.g. sickle cell anaemia, thalassaemia)

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

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

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Premature Birth; beta-Thalassemia

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Gerhard Pichler, Prof

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 17, 2021
• Study Start: June 8, 2020
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

AU (1)