Pluss Advanced Technologies
The company is focused on India as its primary market, but also has plans underway to distribute the device to hospitals in Kenya and South Africa, with contacts listed for distributors in both as of July 2016. It also sees a market for smaller hospitals and clinics in the U.S. and Europe that are looking for low-cost alternatives to higher cost alternatives for hypothermia treatment systems that are currently available.
The product has distributors for South Africa, Kenya, and specific states in India which can be found here.
Goal 3: to improve and promote good health.
Birth asphyxia is the medical condition resulting from lack of oxygen in a newborn infant. It is a major cause of Hypoxic Ischemic Encephalothapy and consequential brain damage or even death. Therapeutic hypothermia induced by cooling to around 33 °C for three days after birth is the prescribed treatment.
The World Health Organization estimates that 650,000 babies worldwide die from birth asphyxia each year, though the number of annual instances is notoriously underreported, especially for children who survive. The overwhelming majority of cases—more than 95 percent—occur in less-developed parts of the world. Many mothers from these areas lack access to skilled medical care during pregnancy and childbirth.
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.
Initially the product was distributed through outreach to medical community (conferences, medical education workshops), but later focused on selling through distributors who also play a role in raising awareness of and marketing the usefulness of the product.
MiraCradle is present in 88 hospitals across India as of August 2016^(Interview with representative).
Device Weight: 13 kg; Dimensions: 620mm x 460mm ; Lifetime: 3 years
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 has 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 temperature decrease below 33°C, use warmer to increase temperature.
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.
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)
Thomas, N., Chakrapani, Y., Rebekah, G., Kareti, K., Devasahaym, S. Phase Changing Material: An Alternative Method for Cooling Babies with Hypoxic Ischaemic Encephalopathy. Neonatology. 2015;107:266-270.
A list of highlighted publications are located on the company website.
Clinical studies and trials with hospitals and physiciansInterview with representative.
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