Actively Recruiting
Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates
Led by University of Pecs · Updated on 2025-02-19
100
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- Patients under 2 years of age undergoing elective surgery lasting more than 30 minutes at the University of Pécs, Department of Paediatrics
- Written consent for participation provided by the patient's parent, guardian, or legal representative
You will not qualify if you...
- Patients who cannot be moved (e.g., post-operative abdominal or thoracic surgery, presence of chest tubes, hemodynamic instability, need for continuous ECG monitoring, or use of an external pacemaker)
- Parent, guardian, or legal representative does not consent or withdraws consent at any time
- Patients older than 2 years (for Substudy 2)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Pécs, Department of Obstetrics and Gynaecology
Pécs, Baranya, Hungary, 7624
Actively Recruiting
2
University of Pécs, Department of Paediatrics
Pécs, Baranya, Hungary, 7624
Actively Recruiting
Research Team
A
András Garami, MD, PhD
CONTACT
K
Kata Fekete, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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