Prevention Strategies for Reducing Admission Hypothermia in Preterm Infants: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240323006

Enrollment

128

Registered

2024-03-23

Start date

2024-04-25

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 infants Hypothermia Newborn Preterm Prevention

Interventions

The bubble wrap used in this study is a two-layer film bubble material manufactured from food-grade, low-density polyethylene with a thickness of 35 grams and bubbles of 1 cm in diameter. After resusc

Experimental Device,Experimental Device

Bubble wraps (BW) group,Reusable warm gel packs (WGP) group

Eligibility

Sex/Gender

All

Age

No minimum to 1 Hours

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Thailand

Contacts

Public ContactSirada Chongthavornvasana

Mahidol University

chong.sirada@gmail.com66896917102

Outcome results

None listed

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