Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates
Recruiting now
Conditions studied: Neonatal Hypothermia, Brown Adipose Tissue, Preterm and Term Infants, Neonate, Thermogenesis, Blood Markers
In brief
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.
Key facts
- Study ID
- NCT06803069
- Run by
- University of Pecs
- People needed
- 100
- Starts
- 2024-07-01
- Expected to finish
- 2029-07-01
- Last updated by the study team
- 2025-02-19
Who can join
Age: any, up to 2. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- For Substudy 1: Patients admitted to the Neonatal Intensive Care Unit at the University of Pécs, Department of Obstetrics and Gynaecology (premature infants or those in neonatal intensive care).
- For Substudy 2: Patients under 2 years of age undergoing elective surgery lasting more than 30 minutes at the University of Pécs, Department of Paediatrics.
- For both substudies: Written consent for participation in the study has been provided by the patient's parent, guardian, or legal representative.
You may not qualify if…
- For both substudies: If the patient cannot be mobilized (e.g., during the post-operative phase of abdominal or thoracic surgery; presence of chest tubes for pneumothorax or other reasons; hemodynamic instability; need for continuous electrocardiogram (ECG) monitoring; or use of an external pacemaker).
- The patient's parent, guardian, or legal representative does not consent to the study or withdraws their consent at any point.
- For Substudy 2: if the patient is older than 2 years.
Where it is running
- University of Pécs, Department of Obstetrics and Gynaecology — Pécs, Baranya, Hungary (enrolling)
- University of Pécs, Department of Paediatrics — Pécs, Baranya, Hungary (enrolling)
Full record on ClinicalTrials.gov
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