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Efficacy of Gel-based Thermal Mattress for Prevention of Hypothermia in Preterm Newborn

Efficacy of Gel-based Thermal Mattress for Prevention of Hypothermia in Preterm Newborn

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240912002
Enrollment
100
Registered
2024-09-12
Start date
2023-10-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia in preterm newborns Preterm newborns Hypothermia prevention Gel-based thermal mattress Hydroxyethyl cellulose Premature infant care Neonatal hypothermia Hypothermia in preterm infants Traditional warming methods Neonatal intensive care Thermal mattress safety Incidence of hypothermia

Interventions

The body temperature of newborns in the intervention group will be continuously measured using a rectal thermometer until they reach 4 hours of age. After that, the gel will be removed and temperature
Experimental Device,No Intervention No treatment
Gel-based thermal mattress ,Standard of care

Sponsors

Faculty of Medicine, Srinakharinwirot University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
24 Weeks to 35 Weeks

Inclusion criteria

Inclusion criteria: 1. Newborns with a gestational age, estimated through obstetric evaluation, of less than or equal to 35 weeks who are admitted to the Neonatal Intensive Care Unit (NICU) or the Semi Neonatal Intensive Care Unit (Semi-NICU) for critical neonatal care and monitoring

Exclusion criteria

Exclusion criteria: 1. Newborns who did not undergo neonatal resuscitation in the delivery room or operating room, such as those born in the emergency room or delivered before reaching the hospital 2. Newborns diagnosed with congenital anomalies 3. Newborns whose first-degree relatives do not consent to participation in the research or cannot be contacted for consent

Design outcomes

Primary

MeasureTime frame
Incidence of hypothermia on admission at NICU or Semi-NICU Rectal temperature lower than 36.5 degree celsius detected through continuous rectal temperature monitoring

Secondary

MeasureTime frame
Initial temperature upon admission On admission Rectal temperature ,Incidence of skin burns Within 4 hours of birth Burns are classified as first-, second-, or third-degree based on depth and severity, which will be assessed by physical examination every hour for 4 hours,Incidence of hypoglycemia Within 24 hours of birth Blood sugar level below 40 mg/dL,Incidence of respiratory distress in newborns Within 24 hours of birth Healthcare professionals establish the diagnosis through a comprehensive clinical assessment, including physical examinations, chest X-rays, and evaluation of oxygen levels,Incidence of Grade 3 and 4 intraventricular hemorrhage Within admission period Bedside ultrasound performed by a general physician, with confirmation by a radiologist in suspected cases,Incidence of death before discharge from the hospital Before discharge from the hospital Absence of vital signs, lack of response to stimuli, and unsuccessful resuscitation efforts after 20 minutes may indicate death, confirmed by the absence of heart activity on ECG,Incidence of metabolic acidosis Within 24 hours of birth Bicarbonate level less than 20 mmol/L, or pH less than 7.35 with a base deficit greater than 5 mmol/L,Incidence of Hyperthermia From birth to admission Rectal temperature higher than 37.5 degree celsius detected through continuous rectal temperature monitoring

Countries

Thailand

Contacts

Public ContactPornpimon Janyoungsak

Faculty of Medicine, Srinakharinwirot University

kikkook17@gmail.com0642399516

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026