RecruitingNCT06803069

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

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)


Sponsor

University of Pecs

Enrollment

100 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Max Age: 2 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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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Locations(2)

University of Pécs, Department of Obstetrics and Gynaecology

Pécs, Baranya, Hungary

University of Pécs, Department of Paediatrics

Pécs, Baranya, Hungary

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NCT06803069


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