A cheap and simple device that aims to deliver medicines or nutrients to babies safely, easily, and in the right dosage while they feed could be a major tool in tackling infant mortality, according to a team of researchers from the University of Cambridge, University College London School of Pharmacy, UC Berkeley, and UT Southwestern Medical Centre
The team has now set up the company JustMilk to develop the device, and will begin non-clinical user acceptability trials in South Africa in autumn 2014.
Currently more than three million babies die each year within a month of being born, the majority of whom could be saved with appropriate administration of drugs such as antibiotics, antimalarials, antiretrovirals or nutrients to prevent and treat diarrhoea.
However, giving medicines to babies is challenging. The most common method is to administer liquid droplets or powders dispersed in water through devices such as oral syringes, droppers or medicinal spoons. These routes can be imprecise since carers can make errors in measuring out the medicines and the baby may cough and spit during delivery. In developing countries the problem is exacerbated by hygiene challenges, with many people lacking the facilities to ensure hygienic delivery of droplets or access to clean water in which to disperse powders.
The team’s solution is a disposable nipple shield made from thin silicone, into which a tablet is placed before feeding which then disperses in breast milk as the baby feeds normally. This may increase the likelihood that the baby will accept the drug because it is delivered in a natural setting.
Although nipple shields are commonly used to protect the breast during feeding or to help a baby that has trouble latching on, adapting them to deliver medicines is complex. For example, the fat content of human milk can vary up to threefold during a single feed, meaning that the tablet must be capable of consistently releasing the required dose to an infant well within a feed despite changes in environment. User comfort and acceptability are also vital, since breastfeeding is critical especially in developing countries and the device cannot risk disrupting that.
Current work focuses on simulating the use of device prototypes in non-clinical laboratory tests to identify the physiological elements in breastfeeding which may affect the rate of dosing of agents from the device within a feed.
To manage these challenges, the team is simulating in a laboratory how the behaviour of a feeding baby and changes in the composition of human milk affects the flow of medicine within the device. Using human milk and an apparatus which simulates infant suction and tongue motion on the device, they are investigating a range of infant feeding behaviours and milk compositions which may affect tablet release, and will help determine optimal tablet properties to maximise likelihood of full dosing for all typical feeding behaviours.
While the lab research continues, the team is also developing relationships with organisations and communities in developing countries to ensure that the device will meet real needs. Partners include the University of Venda in South Africa, where non-clinical user acceptability studies will be conducted to gain feedback about comfort, convenience, and usability.
The device concept was invented at the International Development Design Summit 2008. The technical research began through several projects funded by a Gates Foundation Grant Exploration Grant, including a PhD project conducted by co-inventor and JustMilk co-founder Dr. Stephen Gerrard, working with colleagues Professor Nigel Slater and Rebekah Scheuerle, a doctoral student funded by a Gates Cambridge Scholarship. Now a Research Associate at the Department of Chemical Engineering and Biotechnology, University of Cambridge Dr Gerrard says:
“This is a really exciting opportunity to develop a simple and affordable but extremely effective solution to poor infant health in developing countries. We are acutely conscious of the importance of breast feeding and it would be one hundred per cent unacceptable to do anything to disrupt it. We are establishing partnerships to work alongside communities and especially women in countries such as South Africa to develop the device. Most recently we have established collaboration with Professor Vhonani Netshandama at the University of Venda to develop the device. This was made possible through JustMilk team member Aspen Flynn working closely with Professor Netshandama over the past 6 months. We are confident that we will develop a product that women will be comfortable using and that babies will find acceptable.”
“Although we developed this primarily as a tool in developing countries, it has useful applications for parents in high-income countries too. Getting medication into babies can be tricky wherever you are, and this could be a cheap and easy solution which also advocates the practice of breastfeeding.”
Dr Eliot Forster, Executive Chair of MedCity, launched by Mayor of London Boris Johnson in April 2014 to attract investment and promote entrepreneurship in the London-Oxford-Cambridge life sciences ‘golden triangle’, says:
“This demonstrates that the most innovative ideas are not always the most complicated. Stephen became aware of a pressing problem as a student, looked for a way that he could help to solve it, and came up with a simple but ingenious idea that he has pursued and refined in partnership with an international team and, crucially, with the people who are going to use it. His product has huge potential to improve health and save lives, as well as being a serious commercial proposition.”
JustMilk has received funding from agencies including the UK ESPCR, Clinton Global Initiative University, and through the Saving Lives at Birth Scheme which includes the Gates Foundation, USAID, the UK Department for International Development (DFID), the Norwegian Government and Grand Challenges Canada.
To get in touch with the JustMilk team email firstname.lastname@example.org.