NCT06803069 Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates
| NCT ID | NCT06803069 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pecs |
| Condition | Neonatal Hypothermia |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-07-01 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Tamás Kövesi, MD, PhD
PRINCIPAL INVESTIGATOR
University of Pecs, Department of Anaesthesiology and Intensive Therapy
Frequently Asked Questions
Who can join the NCT06803069 clinical trial?
This trial is open to participants of all sexes, up to 2 Years, studying Neonatal Hypothermia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06803069 currently recruiting?
Yes, NCT06803069 is actively recruiting participants. Contact the research team at andras.garami@aok.pte.hu for enrollment information.
Where is the NCT06803069 trial being conducted?
This trial is being conducted at Pécs, Hungary, Pécs, Hungary.
Who is sponsoring the NCT06803069 clinical trial?
NCT06803069 is sponsored by University of Pecs. The principal investigator is Tamás Kövesi, MD, PhD at University of Pecs, Department of Anaesthesiology and Intensive Therapy. The trial plans to enroll 100 participants.