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)

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 2
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Hungary
University of Pécs, Department of Obstetrics and Gynaecology
RECRUITING
Pécs
University of Pécs, Department of Paediatrics
RECRUITING
Pécs
Contact Information
Primary
András Garami, MD, PhD
andras.garami@aok.pte.hu
+3672536000
Backup
Kata Fekete, MSc
kata.fekete@aok.pte.hu
+3672536000
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2029-07-01
Participants
Target number of participants: 100
Treatments
Preterm neonates
Group of neonates who were born before the 37th gestational week.
Full-term neonates
Group of neonates who were born after the 37th gestational week.
Related Therapeutic Areas
Sponsors
Leads: University of Pecs

This content was sourced from clinicaltrials.gov