Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates

NCT06803069 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-02-19

No results posted yet for this study

Summary

Newborns have thermoregulatory mechanisms that differ from those of adults. Instead of producing heat through shivering, newborns primarily rely on non-shivering thermogenesis by the brown adipose tissue. The development of this thermogenic tissue starts around the 26th gestational week and continues until shortly before birth, after which no further growth occurs. As a result, premature infants, who have less developed brown fat, are more prone to reduced heat production and are at higher risk for hypothermia. There are few human studies examining the thermoregulatory differences and mechanisms between full-term and premature neonates, and the findings remain inconclusive.

In this study, the investigators aim to conduct a prospective, observational research. Researchers will compare body temperature, brown adipose tissue activity, and specific plasma markers between full-term and premature neonates in insensive care units and during elective surgeries.

Conditions

  • Neonatal Hypothermia
  • Brown Adipose Tissue
  • Preterm and Term Infants
  • Neonate
  • Thermogenesis
  • Blood Markers

Sponsors & Collaborators

  • University of Pecs

    lead OTHER

Principal Investigators

  • Tamás Kövesi, MD, PhD · University of Pecs, Department of Anaesthesiology and Intensive Therapy

  • András Garami, MD, PhD · University of Pecs, Institute for Translational Medicine

  • Simone Funke, MD, PhD · University of Pecs, Department of Obstetrics and Gynaecology

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2027-09-30
Completion
2029-07-01

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06803069 on ClinicalTrials.gov