Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding
NCT07453264
Neonatal Adaptation, Neonatal Hypothermia
Kocaeli, darıca, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT06803069
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.
Interested in participating?
Request InfoUp to 2 year
All sexes
Observational
University of Pécs, Department of Obstetrics and Gynaecology, Pécs, Baranya, Hungary
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years
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: 3 years
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
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 in g/l
Time frame: 3 years
Hematocrit level in %.
Time frame: 3 years
Glucose level in mmol/l.
Time frame: 3 years
bilirubin in µmol/l, AST in IU/l, ALT in IU/l, GGT in IU/l, LDH in IU/l.
Time frame: 3 years
urea in µmol/l, creatinine in µmol/l.
Time frame: 3 years
thyroid hormones in mIU/l (TSH, T3, T4).
Time frame: 3 years
CRP in mg/l and PCT in ng/ml.
Contact information is provided by the study sponsor or research team.
András Garami, MD, PhD
CONTACT
+3672536000 ext. 38607
Kata Fekete, MSc
CONTACT
+3672536000 ext. 38604
University of Pecs
Other
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)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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