Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:42 PM
Study NCT ID:
NCT06803069
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates
Sponsor:
University of Pecs
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Test Methods:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NKFIH-FK-138722 | OTHER_GRANT | National Research, Development and Innovation Office | View |