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

Neonates satisfying the eligibility criteria will be enrolled in the study after obtaining written informed consent from the parents/legal guardian/caretaker

Eligible newborns will then be randomized using a digitally generated sequence into two groups

Group A will receive a Novel Self Warming Blanket and group B will receive the normal blanketThe procedure of randomization will be conducted by a person who has no role in the collection of data randomization analysis of data or allocation of the intervention A sequence with a random order will be derived using a software application. Randomization of the sequence will be further enhanced by generating tables of variable block sizes using computer software Concealment of the allocation of the intervention will be implemented by the usage of opaque chronologically numbered sealed envelopes each corresponding to the assigned sequence An open-label study design has been adopted due to the operational requirement for air activation of the heating element integrated within the self warming blanket A structured questionnaire will be used to gather demographic information and a comprehensive history regarding antenatal details maternal medication use etc will also be recorded Additionally a thorough physical examination will be conducted to assess for any systemic involvement.

This Self-Warming blanket is specifically engineered to integrate two essential components a thermal blanket and a heating element The blanket is constructed from hypoallergenic fabric combined with hospital-grade polypropylene material and polyurethane foam, providing insulation to minimize heat loss in  infants. While the insulating layer helps to slow down the loss of body heat, it alone is insufficient to maintain a thermoneutral temperature, as preterm infants lack the ability to generate adequate heat on their own To address this, the design includes a dedicated compartment for a heating element, which serves as a controlled and consistent external heat source This heating component is designed to maintain a stable thermoneutral temperature for up to 8 hours, ensuring the infant remains warm during critical periods such as transport or postnatal stabilizationThe heating element is strategically positioned on the back side of the blanket and is separated from the infant’s contact surface by four protective layers comprising fabric and foam. This multilayered barrier ensures that the heating element remains completely isolated thereby eliminating any risk of direct contact with the newborn

The heating component utilizes ready-to-use air-activated heat packs which are widely employed globally for thermal insulation in cold environments These heat packs contain only non-toxic substances including iron salt water and insulating material such as vermiculite and activated carbon These materials are securely enclosed within multiple protective layers to prevent any leakage of the active ingredients

Upon exposure to air, the iron within the mixture undergoes a controlled oxidation process converting to iron oxide (rust) which generates heat Owing to the gradual nature of this chemical reaction the heating pack is engineered to deliver warmth in a slow sustained manner maintaining a consistent temperature over an extended duration.

Utilizing air activated heating technology, the Self Warming blanket  becomes ready for use within 15 minutes of exposure to air and provides consistent warmth for up to 8 hoursAfter use, a heating element made with all non-toxic, eco-friendly ingredients can be safely disposed of with solid wasteThe product is tested within the laboratory for obtaining the temperature profile of the surface in contact with the babyThe temperature remains between 36.5 – 38.0 °C and slowly decreases over a period of time. There is no variation in Warm and Cold temperature while using the blanket

Following the initiation of the intervention, all newborns will be monitored continuously using a temperature probe with set limits with an alarm Assessment of the Prechtl score will also be done hourly over the next 8 hours to assess their condition After  8 hours of blanket usage, newborns will undergo a re-evaluation of the same parameters at 0 5 and 30-minute intervals This approach will facilitate a more detailed assessment of their temperature stability and ensure continuous and appropriate monitoring of their overall condition Any adverse effect noted during the usage of blanket will be documented