Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates
NCT ID: NCT06803069
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-07-01
2029-07-01
Brief Summary
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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.
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Detailed Description
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Both substudies involve the use of a FLIR C3 mobile thermal camera to create thermograms. Thermal images of the full-term and preterm infants are taken from a distance of 20 cm while the participants lie in a supine position. The area examined spans from the upper edge of the diaper to the top of the head.
Substudy 1:
1\. a) In case of neonates in the intensive care unit or waiting for short procedures (e.g., ophthalmic surgery), thermal images are taken before transport to the operating room and after surgery, before transferring back to the ward. For infants receiving incubator care, both images are taken inside the transport incubator. The test duration is about 5 minutes.
1\. b) Images are captured before kangaroo care, before and after transferring the infant to the ward (both images taken in the transport incubator if the infant is in incubator care).
1\. c) Thermal images are taken before and after the insertion of an epicutaneous cannula.
1. d) For post-asphyxic infants undergoing therapeutic hypothermia, images are taken immediately before starting cooling on the therapeutic mattress, once midway through the cooling process; once immediately after reaching the target core temperature; then daily while in the hypothermic state; once immediately before the rewarming process, and every hour during rewarming until the desired core temperature is reached.
Substudy 2:
2. a) In case of neonates waiting for surgeries lasting more than 30 minutes, thermal images are taken before the surgery; every 10 minutes during the operation; after surgery, following the same protocol as in Substudy 1.
2\. b) Thermal images are taken before and after inserting a central cannula.
Parameters recorded in the substudies:
1. Blood tests, including c-reactive protein (CRP), procalcitonin (PCT), blood count, glucose, bilirubin, thyroid hormones, urea, creatinine, glutamate oxaloacetate transaminase (GOT), glutamate pyruvate transaminase (GPT), lactate dehydrogenase (LDH), gamma-glutamyl transferase (GGT), and blood gas, as part of routine blood sampling.
2. Rectal core temperature, as well as episodes of shivering or heat production.
3. Changes in body temperature during surgery along with other routinely measured physiological parameters (e.g., blood pressure, respiratory indicators).
4. Type and dosage of anesthetics used, as well as any side effects (e.g., post-surgery vomiting).
5. Additional parameters such as gestational age, Apgar score, birth weight, body weight at the time of examination, and environmental temperature (e.g., clinic, incubator, operating room).
Examination process:
The parents/guardians/legal representatives of the selected patients will be provided with detailed information, and consent forms will be signed by them.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Preterm neonates
Group of neonates who were born before the 37th gestational week.
No interventions assigned to this group
Full-term neonates
Group of neonates who were born after the 37th gestational week.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Years
ALL
Yes
Sponsors
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University of Pecs
OTHER
Responsible Party
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Principal Investigators
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Tamás Kövesi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pecs, Department of Anaesthesiology and Intensive Therapy
András Garami, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pecs, Institute for Translational Medicine
Simone Funke, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pecs, Department of Obstetrics and Gynaecology
Locations
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University of Pécs, Department of Obstetrics and Gynaecology
Pécs, Baranya, Hungary
University of Pécs, Department of Paediatrics
Pécs, Baranya, Hungary
Countries
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Central Contacts
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Facility Contacts
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References
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Nedergaard J, Cannon B. Brown adipose tissue as a heat-producing thermoeffector. Handb Clin Neurol. 2018;156:137-152. doi: 10.1016/B978-0-444-63912-7.00009-6.
Symonds ME, Pope M, Sharkey D, Budge H. Adipose tissue and fetal programming. Diabetologia. 2012 Jun;55(6):1597-606. doi: 10.1007/s00125-012-2505-5. Epub 2012 Mar 9.
Lunze K, Hamer DH. Thermal protection of the newborn in resource-limited environments. J Perinatol. 2012 May;32(5):317-24. doi: 10.1038/jp.2012.11. Epub 2012 Mar 1.
Silverman WA, Sinclair JC. Temperature regulation in the newborn infant. N Engl J Med. 1966 Jan 13;274(2):92-4 contd. doi: 10.1056/NEJM196601132740207. No abstract available.
Knobel R, Holditch-Davis D. Thermoregulation and heat loss prevention after birth and during neonatal intensive-care unit stabilization of extremely low-birthweight infants. J Obstet Gynecol Neonatal Nurs. 2007 May-Jun;36(3):280-7. doi: 10.1111/j.1552-6909.2007.00149.x.
Lidell ME. Brown Adipose Tissue in Human Infants. Handb Exp Pharmacol. 2019;251:107-123. doi: 10.1007/164_2018_118.
Other Identifiers
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NKFIH-FK-138722
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BM/17552-3/2024
Identifier Type: -
Identifier Source: org_study_id
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