Prevention Strategies for Reducing Admission Hypothermia in Preterm Infants: A Randomized Controlled Trial
Phase 3
- Conditions
- Hypothermia in preterm infantsHypothermia Newborn Preterm Prevention
- Registration Number
- TCTR20240323006
- Lead Sponsor
- Mahidol University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 128
Inclusion Criteria
Preterm infants with gestational age (GA) 24-33+6 weeks or estimated fetal weight <2,000 g who are admitted to NICU or SCN within 1 hour after delivery at Ramathibodi Hospital
Exclusion Criteria
Neonates with congenital anomalies, including abdominal wall defects, neural tube defects, imperforated anus; chromosomal defects; maternal fever (temperature > 38 degree celcius); and inability to obtain parental consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of admission hypothermia Before transportation and upon admission to the Neonatal Intensive Care Unit (NICU) or Special Care Nursery (SCN) Rectal temperature below 36.5 degree celcius
- Secondary Outcome Measures
Name Time Method The incidence of admission hyperthermia Before transportation and upon admission to the Neonatal Intensive Care Unit (NICU) or Special Care Nursery (SCN) Rectal temperature exceeding 37.5 degree celcius,Duration of stabilization After birth, the timeframe extends until the infant is transported using an incubator Timing during neonatal resuscitation, which commences after birth and continues until just before transportation,Duration of transportation After completing neonatal resuscitation, the period until admission to the ward The timing begins with moving the infant into an incubator, followed by transporting the infant from the labor or operation room to the admission ward,Local skin reactions from contacting reusable warm gel packs After using the reusable warm gel packs The degree of a skin burn at the skin contact surface is classified into first, second, and third-degree burns