Feasibility, Acceptability, and Usability testing in Kenya of NeoWarm: An innovative biomedical device to prevent newborn hypothermia in low-middle income country
| Principal Investigator | Sherri Bucher, PhD, MA (IUSOM) |
| International Collaborator(s) | Prof. Fabian Esamai (Moi University); Dr. David Muyodi (Moi University) |
| Project Type | |
| Project Title | Feasibility, Acceptability, and Usability testing in Kenya of NeoWarm: An innovative biomedical device to prevent newborn hypothermia in low-middle income countries |
| Priority Area | Infant and maternal health; reduction of morbidity and mortality |
| The Intervention | Hypothermia, and complications caused by hypothermia, such as feeding and breathing problems, are thought to underlie almost 4 million newborn deaths each year. Premature and low birthweight babies, in particular, are extremely susceptible to developing, and dying from, low body temperature. The vast majority of these deaths occur in resource-limited settings, where access to “high tech” incubators or “low tech” “kangaroo mother care” programs, is not feasible. What is needed, to “bend the curve” on hypothermia-related neonatal mortality, are innovative, feasible, affordable, safe, effective, and culturally-acceptable “middle tech” solutions to bridge the current gap in thermoregulatory support solutions for vulnerable babies. Our multidisciplinary, international investigative team will perform feasibility, acceptability, and usability testing, in Kenya, of a built prototype of an innovative biomedical thermoregulatory support device called “NeoWarm.” it is feasible to develop an effective and affordable biomedical device which is safe and acceptable in a variety of global settings, among multiple stakeholders and end-users, and will serve as a “middle-tech” solution to bridge the current gap between poorly scaled “low-tech” kangaroo mother care (KMC, or skin-to-skin care) and “high-tech,” often inaccessible, incubator care. The NeoWarm biomedical device is NOT designed to “replace” either KMC (low-cost solution recommended by the World Health Organization) or incubator care (the “gold standard” for nursing support of sick preterm infants), but rather, to augment both solutions, while simultaneously serving as an effective, feasible, acceptable, low-cost addition to the toolkit by which caregivers and health workers can effectively prevent and manage newborn hypothermia in resource-limited settings. This pilot project will lay the groundwork for expanded collaboration on an innovative and life-saving initiative among North American and Kenyan investigators. |
| Key Facilitators | Based on feedback from the feasibility and acceptability study, the biomedical device is currently undergoing additional integration of wireless sensor technology with partners from Purdue University Weldon School of Biomedical Engineering. The Indiana CTSI is developing a program focused on reciprocal innovation that seeks to support the identification, adaptation, implementation, and evaluation of promising interventions developed at LMIC partner sites for use in Indiana. This infrastructure provides funding and other resources to adapt interventions to a US context. Additional partnerships include Indiana University School of Medicine, Moi University School of Medicine, Department of Biomedical Engineering, and the Global Network for Women’s and Children’s Health Research. |
| Target Population | Premature infants; low birthweight infants; small-for-gestational age; neonatal transport |
| Process to Implementation | This intervention has not yet been implemented in Indiana but is being piloted in Kenya. If the pilot findings show positive outcomes, potential exists to apply this intervention to low resourced clinical settings in Indiana and the US, particularly among opioid-exposed newborns. Following identification of potential pilot sites in Indiana, this intervention could be adapted and piloted for use in the US clinical context using support from the Indiana CTSI and other health partners in Indiana, e.g. State Department of Health, IU Health, Eskenazi, and other public health centers. |
| Key Stakeholders | Stakeholders include infants, their family caregivers, community leaders (e.g., pastors and village elders), and health care providers (facility and community-based), as well as researchers, and administrators. We anticipate in transferring to the US that there would need to be similar stakeholders that would need to be engaged. |
| Scaled or Transferred? | The aim is to work toward scaling this process into the US setting. In particular, we believe that this innovation has potential feasibility within the United States to improve non-pharmacological management of infants exposed to opioids in utero who subsequently suffer from neonatal abstinence syndrome. In addition, we believe that this innovation may help improve neonatal transportation of small and sick newborns in various geographies. The built prototype of this biomedical device has undergone extensive feasibility and acceptability testing among a wide variety of stakeholders. It has a wide range of potential applications, to improve neonatal health and well-being, and reduce newborn mortality and morbidity, across a wide number of geographies (high, low, and middle-resource countries) and use cases (premature infants; opioid-exposed infants; transport of sick and small babies). |
| Type of Research | Drawing on our combined expertise in public health, biomedical engineering, and implementation science, we will utilize quantitative and qualitative methods to: (1) Collect detailed baseline information about the current landscape of newborn hypothermia and existing use environment for NeoWarm; (2) Perform feasibility and acceptability assessment of the built NeoWarm prototype among adult end-users and stakeholders in Kenya; (3) Evaluate the device-user interface using a newborn simulator. |
| Published Materials | Patent — Infant thermoregulation and monitoring support system
2016: Watts, T., Siddiki, F., Savita, A. and Bucher, S The NeoWarm Biomedical Device: Assessment of Feasibility and Cultural Acceptability, Identification of Potential Barriers and Challenges, and Stakeholder Mapping, Poster presentation, IUPUI Research Day, Indianapolis, IN, April 8, 2016. 2016: Moore, D., Combs, W., and Bucher, Sţ NeoWarm: Engineering Verification for a Built-Prototype of a Biomedical Device to Prevent Newborn Hypothermia, Poster presentation, IUPUI Research Day, Indianapolis, IN, April 8, 2016 Bucher, S., Combs, W., and Muyodi, D., NeoWarm: Feasibility and Acceptability Testing in Kenya of an Innovative Biomedical Device to Prevent Newborn Hypothermia, Poster Presentation, Indiana CTSI Annual Research Meeting, Indianapolis, IN, September 23, 2016. Juried competition: This poster was one of 12 (out of around 100) selected to be featured at the Indiana Life Sciences Summit (see below). Bucher, S., Combs, W., and Muyodi, D., NeoWarm: Feasibility and Acceptability Testing in Kenya of an Innovative Biomedical Device to Prevent Newborn Hypothermia, Poster Presentation, BioCrossroads Indiana Life Sciences Summit, Indianapolis, IN, October 4, 2016. Juried competition: Selected to receive the BioCrossroads Inaugural Prize for Scientific Presentation Bartlett, M, Brown, J., Bruer, J., Meyers, E., Purkayastha, S., Combs, W., ț Bucher,S. Landscape Analysis and Evaluation of Utility for Wearable and Wireless Sensors to Monitor Infant Vital Signs in a Wearable Biomedical Device, Poster Presentation, IUPUI Student Research Day 2018, IUPUI Center for Research and Learning, Indianapolis, IN, April 6, 2018 Juried competition (Session 2) Bucher, S., Combs, W., Muyodi, D. NeoWarm: Feasibility and Acceptability Testing in Kenya of an Innovative Biomedical Device to Prevent Newborn Hypothermia, March 29 – 30, 2018 (Poster presentation) Purdue University, Global Engineering Programs and Partnerships, I2D Lab Exposition 2018 Bucher, S., Purkayastha, S., Combs W, Esamai, F (2019) NeoInnovate: Integration of mHealth and wearable biomedical device technologies to reduce neonatal morbidity and mortality, 29th International Congress of Pediatrics of the International Pediatrics Association, Panama City, Panama, March 17 -21, 2019. Bucher, S. NeoWarm: Biomedical device innovation to reduce mortality and morbidity among newborns (November 8, 2019), IUPUI Biomedical Engineering Graduate Student Lunch Symposium: Invited Seminar Bucher, S. NeoWarm: Biomedical Innovation to Save Newborns, (November 22, 2019) Indiana University Kelley School of Business: Invited Pitch (MBA students) |
| Year Funded | 2016 |