August 3, 2022
Mobile WACh NEO randomized controlled trial achieves milestone to enroll 5,020 research participants
Newborn care practices and interventions are available to support neonatal survival, but coverage remains a challenge in sub-Saharan Africa, where neonatal mortality is unacceptably high. Many newborns continue to die at home without health care services being sought. The reasons are multifactorial, at the societal, health system, and family levels. Delays recognizing illness and deciding to seek care contribute to up to 80% of neonatal and child deaths.
Launched in 2020, the Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support randomized controlled trial is testing if a two-way SMS platform, known as Mobile WACh, that combines automated SMS messaging and dialogue with a healthcare worker can improve neonatal outcomes in Kenya. The research team adapted this approach for intensive neonatal support and evaluation, building multiple messaging “tracks” into the system to address conditions that put infants at higher risk. Mobile WACh embraces the convenience of SMS messaging by engaging mothers through mobile text communication and bringing timely information and support in the palm of their hands. It asks critical questions at crucial times to assess the needs and health of newborns and assist in care-seeking decisions, as well as allowing for dialogue with a healthcare worker for any questions or concerns The study protocol paper, describing the entirety of the study invention and outcomes, was published in BMJ Open in 2021.
On June 30, 2022, the trial completed enrollment of its 5,020 participants. 2,510 pregnant women will receive automated SMS messages with prompts to reply and have the ability to both respond to and initiate SMS dialogue, while the other 2,510 pregnant women will not. The goal of the trial is to determine the effect of Mobile WACh NEO’s approach on neonatal mortality, essential newborn care, care seeking, and maternal mental health in the first six weeks postpartum.
The study’s key personnel include Principal Investigator Dr. Jennifer Unger (Women and Infants Hospital of Rhode Island), Site Principal Investigator Dr. John Kinuthia (Kenyatta National Hospital) and Co-Investigators Drs. Manasi Kumar (Aga Khan University/University of Nairobi), Millicent Masinde and Dalton Wamalwa (Kenyatta National Hospital), Anna Hedstrom (Seattle Children’s Hospital), and Barb Richardson and Keshet Ronen (University of Washington). Key staff include Study Coordinator Brenda Wandika, Assistant Study Coordinators Peninah Kithao and June Moraa, Data Manager Lusi Osborn (Kenyatta National Hospital) and Research Coordinator Jenna Udren (University of Washington). They credit the outstanding study nurses and retention officers at the six trial sites in Kenya to help reach this major milestone.
Follow-up of the research participants will continue until February 2023. The team recently hired a Research Assistant, Epidemiology graduate student Olivia Schultes, to work on analyses and start work on data cleaning and finalizing outcome data. We look forward to learning more about the study’s progress!