Actively Recruiting

Age: 0 - 2Years
All Genders
Healthy Volunteers
ID06803069

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)

Led by University of Pecs · Updated on 2025-02-19

100

Participants Needed

2

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the differences in how newborns and premature infants regulate body temperature, focusing on the role of brown adipose tissue and specific blood markers. The study compares full-term and premature neonates in intensive care units and during elective surgeries to better understand why premature infants are more prone to hypothermia. This prospective, observational research aims to fill gaps in knowledge about thermoregulation in these vulnerable populations. The study uses a mobile thermal camera to take detailed thermal images of neonates from the upper diaper area to the head, capturing temperature changes in various situations such as before and after surgery, kangaroo care, or therapeutic hypothermia. Blood tests measuring inflammatory markers, thyroid and liver function, glucose, and other parameters are collected alongside physiological data like core temperature and anesthetic use. The research includes two groups: premature infants born before 37 weeks gestation and full-term infants born after 37 weeks. Parents or legal guardians provide consent before participation. The study involves monitoring neonates in the intensive care unit or during elective surgeries lasting over 30 minutes, with thermal imaging and blood sampling performed throughout these periods. Researchers assess brown adipose tissue activity through temperature data collected over two years. Additional laboratory markers related to thermogenesis and organ function are followed for up to three years to understand the biological mechanisms behind temperature regulation in newborns.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 2Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients admitted to the Neonatal Intensive Care Unit (premature or neonatal intensive care patients).
  • Patients under 2 years old undergoing elective surgery lasting more than 30 minutes.
  • Written consent provided by parent, guardian, or legal representative.
Not Eligible

You will not qualify if you...

  • Patients who cannot be moved due to post-operative conditions, chest tubes, hemodynamic instability, continuous ECG monitoring, or use of an external pacemaker.
  • Lack of consent or withdrawal of consent by parent, guardian, or legal representative.
  • Patients older than 2 years (for elective surgery group).

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Before, during, and after surgical or intensive care interventions as applicable

Participants undergo thermal imaging and routine blood tests to assess temperature regulation and related physiological parameters.

Multiple imaging sessions before, during, and after surgery or intensive care procedures; blood tests as part of routine care

Long-term Monitoring

Duration - Up to 3 years

Participants are observed over time to collect temperature data and laboratory parameters related to thermogenesis and other physiological functions.

Periodic assessments depending on clinical care and follow-up schedules

Trial Site Locations

Total: 2 locations

1

University of Pécs, Department of Obstetrics and Gynaecology

Pécs, Baranya, Hungary, 7624

Actively Recruiting

2

University of Pécs, Department of Paediatrics

Pécs, Baranya, Hungary, 7624

Actively Recruiting

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Research Team

A

András Garami, MD, PhD

K

Kata Fekete, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Thermoregulation and heat loss prevention after birth and during neonatal intensive-care unit stabilization of extremely low-birthweight infants.

Robin Knobel, Diane Holditch-Davis

https://pubmed.ncbi.nlm.nih.gov/17489935