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Project Firefly: Infant Phototherapy

Read about the success of the Project Firefly clinical trial which began December 5th, 2011, at the National OBGYN Hospital in Hanoi, Vietnam.

The Need

Jaundice caused by hyperbilirubinemia affects sixty percent of all newborns worldwide, and a higher percentage in Asia. Of these jaundiced newborns, ten percent will develop permanent, long-term disabilities and even brain damage without treatment. Phototherapy is the only cost-effective treatment for this condition. Firefly is the first low-cost phototherapy device that Vietnamese clinicians trust to use in the room with mothers in rural hospitals--a context that supports an optimal cycle of newborn phototherapy and feeding for rapid and effective treatment. The combination top and bottom phototherapy, robust enclosed housings, table-top size, removable and cleanable single-infant bassinet, and high-tech medical aesthetic make it the most trustworthy, intuitive and effective phototherapy device affordable for low-resource, remote settings in Vietnam and Southeast Asia.

In response, Design that Matters (DtM), the East Meets West Foundation (EMW) and Vietnamese manufacturer MTTS have launched a collaboration to develop a new infant care device that will treat newborn jaundice during the critical first days of life. This effort will build on EMW’s successful Breath of Life program and extensive network of collaborators across Southeast Asia, DtM’s experience in the design of newborn technologies for the poor, and MTTS's expertise in the production and support of context-appropriate medical devices.

EAST MEETS WEST

East Meets West (EMW) has developed the program to specifically target hypothermia, respiratory distress and hyperbilirubimia, and other causes of high infant mortality rates in developing countries. They are now expanding the program from provincial referral hospitals in Vietnam to include both district-level hospitals in Vietnam, and hospitals in lower-resource countries like Cambodia, Laos and Timor. These community clinics lack the the resources (staffing, training, electricity) to take advantage of EMW’s “Breath of Life” NICU suite (warmer, phototherapy, CPAP). They need simpler, less expensive tools that will improve their ability to treat patients without referrals.

These tools include:

• infant warming
• phototherapy for jaundice
• respiratory therapyinfection control
• training: teaching for doctors and nurses

To date, the EMW Breath of Life program has achieved the following:

• 500 CPAP and other medical devices currently in use, each with a three-year parts and service warranty.
• 140 hospitals in the EMW network in four countries (Vietnam, Laos, Cambodia and East Timor).
• Built first-ever NICUs in 20% of Vietnamese provinces, and the first public NICUs in the countries of Laos, Cambodia and East Timor.
• Over 2,000 doctors and nurses trained.
• 15-20,000 babies treated each year.
• Approximately 70% reduction in infant mortality in each hospital where the program is introduced.
• 95% of Vietnamese provincial and big-city hospitals now have an EMW NICU installed and in operation.

In addition, EMW conducts daily monitoring of each hospital in
the network, and twice-annual program evaluation visits to most
hospitals.

The Approach

Project Firefly is part of Design that Matters’ Newborn Technology Development program, created in response to the need for better tools for neonatal healthcare. Our goal in this program is to develop new medical devices that reduce infant mortality and morbidity in developing countries in partnership with leading social enterprises like East Meets West. Our approach is to work with our partners to identify interventions where the opportunity exists to adapt the high-cost and technologically complex devices currently used in the industrialized world to the budgets and circumstances of the developing world.

This program will build on DtM’s experience with infant thermoregulation through our 2007-2008 “car parts” incubator project , and with respiratory therapy through our 2009 low-cost CPAP (continuous positive airway pressure) initiative . These complementary design efforts have received international design awards and attracted the interest of the medical device industry through their innovative, human-centered approach to product design for developing countries. This work has provided us with first-hand research experience in India, Nepal, Bangladesh, Cambodia, Vietnam and Indonesia, close working relationships with experts in neonatology and global health at Harvard Medical School, Massachusetts General Hospital and Brigham and Women’s Hospital, and partnerships with international aid organizations including Medicine Mondiale and the East Meets West Foundation.

The Solution

TRUST: Inexpensive without looking cheap, Firefly provides above-and-below phototherapy at a fixed distance from the infant, eliminating the possibility that users will install the lights incorrectly, and ensuring that the newborn receives effective phototherapy regardless of their orientation. The bottom lights allow the patient to receive effective phototherapy when covered by a blanket (whether in cooler weather or by a worried mother).

CONNECTION: Firefly is sufficiently compact and robust for clinicians to feel comfortable installing the device in the mother’s recovery room. Entire nights of jaundice therapy are lost as rural hospitals have insufficient staff to shuttle the infant between phototherapy in the neonatal intensive care unit (NICU) and feeding in the mother’s recovery room. This new context promotes mother-child bonding, regular feeding and close maternal supervision.

SAFETY: Infection is a leading cause of infant mortality. Firefly’s one-piece, removable, vacuum-formed bassinet is designed to be easily disinfected by hand, providing superior infection control to rural hospital bedding. Furthermore, conventional overhead phototherapy devices effectively encourage rural hospitals to place two or three infants in one bed for simultaneous treatment. Firefly’s bassinet will only hold a single infant, reducing the risk of cross-infection. It is possible to purchase three Firefly units for the cost of one locally-available overhead phototherapy unit, meaning rural hospitals need not compromise between patient volume and infection control.

Learn more about our progress on the DtM Firefly blog or below by reading our feedback from the Firefly clinical trial.

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1: M. Maisels and A. McDonagh, “Phototherapy for Neonatal Jaundice,” New England Journal of Medicine 358:9, 28Feb08