Helping Newborn Babies Stay Warm: A Study of a Novel Self Warming Blanket

Efficacy of a Novel Self-Warming blanket for thermoregulation in Neonates - An Open labelled , parallel arm, Randomized Controlled Trial - NeoSWaT

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094706

Enrollment

Registered

2025-09-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

None listed

Interventions

Intervention1: Novel Self Warming Blanket: Novel Self Warming Blanket will be assigned for 8 hours to the selected participants based on randomisation to check for temerparature stability Intervention

Eligibility

Inclusion criteria

Inclusion criteria: Stable newborn delivered between 30 and 40 weeks of gestation within first 28 days of life

Exclusion criteria

Exclusion criteria: Newborns born before 30 weeks of gestation Critically ill newborn requiring NICU admission Newborn with major congenital malformations

Design outcomes

Primary

Measure	Time frame
Proportion of newborns maintaining normal body temperature (36.5?C to 37.5?C) upon usage of novel self warming blanket vs conventional blanketTimepoint: Proportion of newborns maintaining normal body temperature (36.5?C to 37.5?C) during 8 hours of usage of novel self warming blanket vs conventional blanket	—

Secondary

Measure	Time frame
The trial also aims at evaluating any adverse events reported with usage of these blankets in newbornTimepoint: The newborns will be monitored for any side effects at baseline, as well continuous hourly monitoring will be done till 8 hours of usage of novel self warming blanket vs conventional blanket.	—

Countries

India

Contacts

Public ContactDr Arun Babu T

All India Institute of Medical Sciences, Mangalagiri

pallavisamariya04@gmail.com8424064142

Outcome results