Pluss Advanced Technologies
An affordable cooling device for treating birth asphyxia.
MiraCradle™ – Neonate Cooler is a passive cooling device which uses savE® phase change material (PCM) technology to induce therapeutic hypothermia among newborns suffering from birth asphyxia.
Since India has the highest frequency of deaths from birth asphyxia in the world, it has been considered the main market. However, shipping is currently being made worlwide. Small hospitals and clinics in the US and Europe are also specially interested in low-cost alternatives for therapeutic hypothermia that are currently available.
2258 USD (168,000 INR)Converted in August 2021
Goal 3: Good health and well-being
MiraCradle should be operated by or under the supervision of a medically trained person who is well-versed in the concept of neonatal care and understands the sensitivities for treatment of such newborns.
MiraCradle’s materials are manufactured and mass produced by Pluss Polymers.
MiraCradle is present in 165 hospitals across the globe as of August 2021.
Continuous, Recharging only (V, time required, battery life), OtherDisplay order
The MiraCradle operates with the use of phase change materials (PCM) designed to melt/freeze at the temperatures which would ensure a temperature regulation of the infant between 33 and 34°C for up to 72 hours. The PCM absorbs heat from the baby thereby cooling the baby. The device uses two PCMs which have a melting/freezing temperature of 29°C and 21°C and an insulated cradle to place these PCMs. A gel bed is placed above the PCMs to give a comfortable surface for the baby
Operational requirements as noted in the 2014 WHO Compendium of Innovative Health Technologies for Low-Resource Settings:
Pre-cool the PCMs FS-29 and FS-21 in a refrigerator for a period of 6-8 hours. Place the 3 pre-cooled PCM FS-29 slabs in the insulated cradle. On top, place 2 slabs of PCM FS-21. Place the gel bed above the PCMs. Place the complete set in the bassinet of a standard infant warmer. Place the baby over the gel bed. Use a rectal probe to measure the temperature continuously. If the temperature decrease below 33°C, use a warmer to increase the temperature.
Device Weight: 13 kg; Dimensions: 620 mm x 460 mm
Source: MiraCradle’s Operating Manual
MiraCradle’s website section on maintenance and operation suggests that the product is easy to use and should require zero maintenance. However, they also provide a detailed user manual, training video, and two guides for assembly and temperature monitoring, along with contact information for any queries.
Instructions in the user manual suggest as follows: Replace savE FS-29 PCM and savE FS-21 PCM after they have individually been used 500 times. Do not use either after their expiry dates under any circumstances. Replace Conduction Mattress one year from the date of first use. Do not use Conduction Mattress after expiry date under any circumstances. Replace the temperature indicator on savE FS-29 one year from the date of first use.
3 years, as listed in the 2014 World Health Organization’s Compendium of Innovative Health Technologies for Low-Resource Settings.
Non-electric and able to maintain temp of 33.5 °C for a period of 72 hoursInterview with representative
Neonatologist Niranjan Thomas first began experimenting with and testing gel packs as a cooling treatment nearly a decade ago (relative to Spring 2016) at the Christian Medical College in Vellore, India. The MiraCradle team also beta-tested the product with hospitals in India. A randomised controlled trial was performed in India, finding that MiraCradle’s therapeutic induced hypothermia reduces brain injury rates at the NICU.
Testing has been done by Pluss Advanced Technologies in collaboration with Christian Medical College in Vellore, India. Additionally, UL, a global safety science company, also conducted product and usability testing in order to award CE certification to MiraCradle. The Faculty of Medicine and Health Sciences from the Norwegian University of Science and Technology surpported a clinical trial in India.
Safety instructions are listed in the user manual , such as reviewing the manual and warning/caution labels carefully before use, avoidance of use of damaged contents and contact for replacement, and storage of parts as per instructions. Additionally, ensure that sufficient training is required and that parts are sanitized before use.
A domestic refrigerator is required for freezing the PCM; the temperature of NICU should be maintained above 25°C. Also requires equipment for monitoring the vital parameters of the newborn during treatment (ex. rectal probe)
Catherine, C., Bhat V., Adhisivam, B., Palanivel, C., 2021, Effect of Therapeutic Hypothermia on the Outcome in Term Neonates with Hypoxic Ischemic Encephalopathy—A Randomized Controlled Trial, Journal of Tropical Pediatrics, 67(1).
Aker, K., Støen, R., Thomas, N., 2020, Therapeutic hypothermia for neonatal hypoxic-ischaemic encephalopathy in India (THIN study): a randomised controlled trial, Archives of disease in childhood, 105(4), pp. 405–411.
Prashantha Y.N., Suman Rao P.N., Shashidhar A., 2019, Therapeutic hypothermia for moderate and severe hypoxic ischaemic encephalopathy in newborns using low-cost devices – ice packs and phase changing material, Paediatrics and International Child Health, 39(4), pp. 234-239.
Thomas N., Abiramalatha T., Prashantha YN., Nimbalkar S., 2018, Phase Changing Material for Therapeutic Hypothermia in Neonates with Hypoxic Ischemic Encephalopathy – A Multi-centric Study, Indian Pediatrics, 55(3), pp. 201-205.
Thomas, N., Chakrapani, Y., Rebekah, G., Kareti, K., Devasahaym, S., 2015, Phase Changing Material: An Alternative Method for Cooling Babies with Hypoxic Ischaemic Encephalopathy, Neonatology, 107, pp. 266-270.
A list of highlighted publications are located on the company website.
Clinical studies and trials with hospitals and physiciansInterview with representative.
The company obtained a partnership with Fanem Medical Devices in April, 2021, in order to expand its distribution capacity throughout India.
In context photographs (0)
You can use the form below to contribute a photo of this product.
In context files & documents (0)
Feedback from users, customers & distributors
Please let us know your experience in using this product through comments below.