Clinical Trial

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

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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-25.
Trial Details
NCT Number NCT06803069
Lead Sponsor University of Pecs
Conditions Neonatal Hypothermia, Brown Adipose Tissue, Preterm and Term Infants, Neonate, Thermogenesis, Blood Markers
Enrollment 100 participants
Start Date 2024-07-01
Primary Completion 2027-09 (estimated)
Study Completion 2029-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-02-19