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

Recruitingn/aAges any - 2 YearsAllUniversity of Pecs
NCT06803069 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 prema

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Not listed
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Where

2 sites
University of Pécs, Department of Obstetrics and Gynaecology
Pécs, Hungary
University of Pécs, Department of Paediatrics
Pécs, Hungary
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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