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

Launched by UNIVERSITY OF PECS · Jan 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how newborns, especially those born early (premature), regulate their body temperature, which can be different from adults. Newborns don’t shiver to keep warm like older children and adults; instead, they rely on a special type of fat called brown adipose tissue, which helps generate heat. Premature babies have less of this brown fat, making them more vulnerable to becoming too cold, a condition known as hypothermia. This study aims to look at body temperature, the activity of this brown fat, and certain blood markers in both full-term and premature infants who are in the neonatal intensive care unit or undergoing planned surgeries.

To participate in this study, babies must be either in the neonatal intensive care unit at the University of Pécs or under 2 years old and scheduled for a surgery lasting more than 30 minutes. Parents or guardians must give written consent for their child to join the study. Participants will have their body temperature and blood analyzed, helping researchers understand the differences in how full-term and premature infants manage their temperature. This information is important as it could lead to better care for newborns at risk of hypothermia.

Gender

ALL

Eligibility criteria

• 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.