An observational study in Neonatal Hypothermia, Brown Adipose Tissue and Preterm and Term Infants, sponsored by University of Pecs. Recruiting at 2 sites in Hungary. Open to participants aged Up to 2 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by University of Pecs · Observational
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.
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:
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:
Parameters recorded in the substudies:
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 806 observational studies indexed under Premature Birth.
Browse Premature Birth studies →University of Pecs is the lead sponsor of 106 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study population consist of randomly chosen preterm and full-term neonates.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group of neonates who were born before the 37th gestational week.
Group of neonates who were born after the 37th gestational week.
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.
Time frame: 2 years
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.
Time frame: 3 years
Blood cell counts
Level of red blood cells in T/l, white blood cells in G/l, and platelets in G/l.
Time frame: 3 years
Hemoglobin level
Hemoglobin level in g/l
Time frame: 3 years
Hematocrit level
Hematocrit level in %.
Time frame: 3 years
Glucose level
Glucose level in mmol/l.
Time frame: 3 years
Liver fuction
bilirubin in µmol/l, AST in IU/l, ALT in IU/l, GGT in IU/l, LDH in IU/l.
Time frame: 3 years
Kidney function
urea in µmol/l, creatinine in µmol/l.
Time frame: 3 years
Thyroid function
thyroid hormones in mIU/l (TSH, T3, T4).
Time frame: 3 years
Inflammatory markers
CRP in mg/l and PCT in ng/ml.
Time frame: 3 years
Plan to share: Undecided
Started Jul 2024 (actual). Primary completion is estimated for Sep 2027, 38 months after the start.
Of 372 non-industry observational studies under Premature Birth, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's planned 38 months is close to that.
Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
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