The primary outcome is to determine the ability of the Embrace Infant Warmer to support neonatal thermostability within the range of 36.5oC to 37.5oC, during the study treatment phase, lasting for 4 hours, as determined by axillary or skin probe temperature reading. 

Neither the concerned medical device nor its comparator are listed under notified medical devices, by the Ministry of Health and Family Welfare, Government of India (20/April/2010). Hence the DCGI approval to conduct pilot clinical study for this device is not needed. However the DCGI has been notified on 02/July/2010 and acknowledgment for the same has been received on 13/July/2010. 

The study is intended to be conducted broadly on clinically stable low-birth-weight neonates who need external thermal support to maintain normothermia.

Data analysed from the study thus conducted was submitted and accepted for presentation at the Pediatric Acedemic Societies (PAD), Denever in 2011-"Pilot Randomized Clinical Trial of a Portable Infant Warmer Not Dependent on a Continuous Energy Supply; Rahul A Panicker, PhD1, Kishore Kumar, MD2,3,4, Naveen Bekappa, MD4, Swarna R Bhat, MD4, Karthik N Nagesh, MD4 and Kiran Tauro, MD3. 1Embrace, San Francisco, California, United States; 2Department of Pediatrics and Neonatology, Notre Dame University, Perth, Western Australia, Australia; 3The Cradle, Bangalore, Karnataka, India and 4 Bangalore Neonatal Network at Division of Neonatology, Stanford,Stanford Univeristy, Stanford, California, United States"

Conduct of the study confirms the cinical feasibility of the Embrace Infant Warmer to provide thermoregulatory support for newly born low-birth-weight infants. A multicenter study powered to upscale its application and assess for a potential adverse events is advised.