Neonatal HypothermiaNCT06803069
Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates
An observational study of Neonatal Hypothermia and Brown Adipose Tissue, run by University of Pecs at 2 sites in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Hypothermia, Brown Adipose Tissue, Preterm and Term Infants
- How many people
- 100 participants
- Where
- 2 sitesHungary
- Study dates
- 1 Jul 2024to 1 Jul 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Study population consist of randomly chosen preterm and full-term neonates.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary2 sites, 2 recruiting
- Recruiting
University of Pécs, Department of Obstetrics and Gynaecology
Pécs, Baranya, 7624
Simone Funke, MD, PhD, +3672536370, funke.simone@pte.hu
Gergely Stankovics, MD, gergely.stankovics@pte.hu
- Recruiting
University of Pécs, Department of Paediatrics
Pécs, Baranya, 7624
Tamás Kövesi, MD, PhD, +3672535-832, tamas.kovesi@pte.hu
Zsolt Fehér, MD, +3672535-832, zsolt.feher@pte.hu
About this study
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)
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.
Read the 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:
- 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.
- 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).
- c) Thermal images are taken before and after the insertion of an epicutaneous cannula.
- 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:
- 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.
- b) Thermal images are taken before and after inserting a central cannula.
Parameters recorded in the substudies:
- 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.
- Rectal core temperature, as well as episodes of shivering or heat production.
- Changes in body temperature during surgery along with other routinely measured physiological parameters (e.g., blood pressure, respiratory indicators).
- Type and dosage of anesthetics used, as well as any side effects (e.g., post-surgery vomiting).
- 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
- Neonatal Hypothermia, Brown Adipose Tissue, Preterm and Term Infants, Neonate, Thermogenesis, Blood Markers
- Keywords
- brown adipose tissue, neonate, neonatal hypothermia, preterm, nonshivering thermogenesis, infant, newborn
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature data from the back of neonates revealing brown adipose tissue activity
Primary objective (Primary endpoint):
The thermogram analysis may reveal reduced brown adipose tissue activity in preterm infants, which could contribute to their increased susceptibility to hypothermia during surgeries and intensive care. The temperature values of the head, brown fat, and trunk will be recorded in degrees of Celsius (°C) with thermal imaging. Their difference (e.g., brown fat temperature minus trunk temperature) will be used as a measure of brown fat activity also expressed in °C.
Measured: 2 years
Secondary outcomes (9)
Concentration and count of special laboratory parameters in connection with thermogenesis in neonates
Secondary objective (Secondary endpoint):
Blood test parameters of the newborns will be determined by the accredited Medical Testing Laboratory at the Clinical Centre, University of Pecs. These include blood cell counts [red blood cells (T/l), white blood cells (G/l), and platelets (G/l)], hemoglobin (g/l), hematocrit (%), glucose (mmol/l), bilirubin (µmol/l), thyroid hormones (mIU/l), urea (µmol/l), creatinine (µmol/l), CRP (mg/l), AST (IU/l), ALT (IU/l), GGT (IU/l), LDH (IU/l), PCT (0,5 ng/ml). They will be used to assess correlations between brown fat activity (see Primary Outcome Measure) and blood levels of a given blood parameter.
Measured: 3 years
Blood cell counts
Level of red blood cells in T/l, white blood cells in G/l, and platelets in G/l.
Measured: 3 years
Hemoglobin level
Hemoglobin level in g/l
Measured: 3 years
Hematocrit level
Hematocrit level in %.
Measured: 3 years
Glucose level
Glucose level in mmol/l.
Measured: 3 years
Liver fuction
bilirubin in µmol/l, AST in IU/l, ALT in IU/l, GGT in IU/l, LDH in IU/l.
Measured: 3 years
Kidney function
urea in µmol/l, creatinine in µmol/l.
Measured: 3 years
Thyroid function
thyroid hormones in mIU/l (TSH, T3, T4).
Measured: 3 years
Inflammatory markers
CRP in mg/l and PCT in ng/ml.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Jul 2024
- Primary completionSep 2027 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neonatal HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamás Kövesi, MD, PhD, Principal investigator, University of Pecs, Department of Anaesthesiology and Intensive TherapyAndrás Garami, MD, PhD, Principal investigator, University of Pecs, Institute for Translational MedicineSimone Funke, MD, PhD, Principal investigator, University of Pecs, Department of Obstetrics and Gynaecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803069
- Sponsor's protocol ID
- BM/17552-3/2024
- Other IDs
- NKFIH-FK-138722
- Status last verified
- Oct 2024
- First submitted
- 25 Jan 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30454587Symonds 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.
PubMed 22402988Lunze 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.
PubMed 22382859Silverman 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.
PubMed 5322157Knobel 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.
PubMed 17489935Lidell ME. Brown Adipose Tissue in Human Infants. Handb Exp Pharmacol. 2019;251:107-123. doi: 10.1007/164_2018_118.
PubMed 29675580