Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates

NCT06803069 | Recruiting

• 2 other identifiers: BM/17552-3/2024NKFIH-FK-138722
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (9)

• Concentration and count of special laboratory parameters in connection with thermogenesis in neonates

  3 years

• Blood cell counts

  3 years

• Hemoglobin level

  3 years

• Hematocrit level

  3 years

• Glucose level

  3 years

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Study population consist of randomly chosen preterm and full-term neonates.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (2)

University of Pécs, Department of Obstetrics and Gynaecology

Pécs, Baranya, 7624, Hungary

RECRUITING

University of Pécs, Department of Paediatrics

Pécs, Baranya, 7624, Hungary

RECRUITING

Related Publications (6)

• 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.

  PMID: 30454587 BACKGROUND

• 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.

  PMID: 22402988 BACKGROUND

• 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.

  PMID: 22382859 BACKGROUND

• 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.

  PMID: 5322157 BACKGROUND

• 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.

  PMID: 17489935 BACKGROUND

• Lidell ME. Brown Adipose Tissue in Human Infants. Handb Exp Pharmacol. 2019;251:107-123. doi: 10.1007/164_2018_118.

  PMID: 29675580 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Tamás Kövesi, MD, PhD

  University of Pecs, Department of Anaesthesiology and Intensive Therapy

  PRINCIPAL INVESTIGATOR

• András Garami, MD, PhD

  University of Pecs, Institute for Translational Medicine

  PRINCIPAL INVESTIGATOR

• Simone Funke, MD, PhD

  University of Pecs, Department of Obstetrics and Gynaecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

András Garami, MD, PhD

CONTACT

+3672536000; andras.garami@aok.pte.hu

Kata Fekete, MSc

CONTACT

+3672536000; kata.fekete@aok.pte.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: January 31, 2025
• Study Start: July 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 19, 2025

Record last verified: 2024-10

Locations

HU (2)