Temperature-Controlled Prewarmed Gel Packs for Thermal Stabilization During Neonatal Transport: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260403001

Enrollment

450

Registered

2026-04-03

Start date

2026-04-01

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

Neonatal hypothermia during transport Gel pack, newborn transport

Interventions

A standard hospital warming method will be used. A cloth bag containing 1 kg of mung beans will be heated in a microwave oven (800 W) for 1 minute at maximum power, shaken to distribute heat evenly, t

Active Comparator Device,Experimental Device

Mung bean bag,Temperature-Controlled Prewarmed Gel Packs

Eligibility

Sex/Gender

All

Age

No minimum to 2 Hours

Inclusion criteria

Inclusion criteria: 1. Gestational age 35 weeks or more 2. Stable vital signs

Exclusion criteria

Exclusion criteria: 1. Infants with clinical instability prior to transport 2. Infants with respiratory distress 3. Infants with congenital anomalies 4. Infants requiring transport in an incubator

Design outcomes

Primary

Measure	Time frame
Hypothermia Temperature immediately after arrival at the destination ward Rectal temperature	—

Secondary

Measure	Time frame
Hyperthermia Temperature immediately after arrival at the destination ward Rectal temperature,Burn wound Temperature immediately after arrival at the destination ward Burn wound classification,Change in body temperature before and after transport Pre-transport and post-transport Pre-transport and post-transport body temperature	—

Countries

Thailand

Contacts

Public ContactChaiwat Kormonchai

Phrachomklao Hospital

jun_chaiwat@hotmail.com032709999

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026