Investigating why newborns and premature infants are prone to hypothermia
Official title: Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Infants During Surgical Interventions and in the Intensive Care Unit (Non-Interventional, Single-Center, Prospective Clinical Research)
Run by University of Pecs · NCT06803069 · Data updated 2026-11-12
This study looks at why newborns, especially premature ones, have trouble keeping warm and tries to understand how their bodies manage temperature in different situations.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 2 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Pecs Academic / other |
| Locations | 2 sites (Pécs, Baranya and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | September 2027 |
| Study ends | July 1, 2029 |
| Registry record updated | February 19, 2025 |
| Trial ID | NCT06803069 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include premature infants in neonatal intensive care and children under 2 years undergoing elective surgeries lasting more than 30 minutes.
✕Probably not a fit
Patients who are hemodynamically unstable or unable to be mobilized post-surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the thermoregulatory mechanisms that contribute to hypothermia in newborns, particularly focusing on the differences between full-term and premature infants. Researchers will utilize thermal imaging to assess body temperature and brown adipose tissue activity in neonates in intensive care units and during elective surgeries. The study will involve capturing thermal images before and after various procedures to understand how these factors influence temperature regulation. By comparing these parameters, the study seeks to provide insights into the unique challenges faced by premature infants regarding heat production.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for preventing hypothermia in newborns, particularly in premature infants.
How similar studies have gone: While there is limited research specifically on this topic, the approach of using thermal imaging in neonatal care has shown promise in related studies.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
University of Pécs, Department of Obstetrics and Gynaecology
Pécs, Baranya, Hungary Recruiting -
University of Pécs, Department of Paediatrics
Pécs, Baranya, Hungary Recruiting
Study contacts
- Principal investigator: Tamás Kövesi, MD, PhD — University of Pecs, Department of Anaesthesiology and Intensive Therapy
- Study coordinator: András Garami, MD, PhD
- Email: andras.garami@aok.pte.hu
- Phone: +3672536000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.