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Partner Q&A: A simple solution for saving lives of small and sick newborns

A conversation with Kiersten Israel-Ballard, DrPH, Team Lead Maternal and Child, PATH

About

​Kiersten Israel-Ballard, DrPH, is the Team Lead for PATH’s Integrated Maternal and Child Health and Development program and an Affiliate Associate Professor at the University of Washington Department of Global Health. With more than 20 years of experience, she specializes in optimal infant feeding methods for vulnerable infants in developing countries, particularly those affected by HIV. Currently, she leads PATH's human milk initiative, developing a comprehensive newborn nutrition model, collaborating with local governments, advocating for locally appropriate human milk banking, and establishing global advisory groups to help transform the field. Dr. Israel-Ballard has extensive international experience in Kenya, South Africa, Tanzania, Zimbabwe, Rwanda, Vietnam, and India.

Background

PATH’s work in maternal and newborn health is comprehensive, focusing on systems, innovation, research, and capacity strengthening. For nearly two decades, PATH’s newborn nutrition team has advanced human milk access for small and sick newborns. PATH’s Health Technologies for Women and Children Portfolio advances affordable, high-quality medical devices and technologies to reduce maternal, newborn, and child mortality in LMICs. Innovations include Bubble CPAP, oxygen blenders, and the Nifty Feeding Cup.

What are the most pressing challenges faced by Small and Sick Newborns (SSN)?

The numbers of small and sick newborns worldwide are staggering. WHO estimates 2.5 million newborns die in the first month of life, mostly due to low birth weight or prematurity. About one million survivors have long-term disabilities. The health system is burdened, with one million of these babies needing inpatient care annually. Most small and sick newborns are in low- and middle-income countries (LMICs), where resources, staffing, and infrastructure are limited. These infants face health issues from prematurity, brain injury, infections, jaundice, and congenital conditions.

The most pressing challenge is improving their quality of care, requiring a multi-faceted approach and commitment from governments, funders, and healthcare providers. Investments in healthcare worker training and skills are essential. Innovation is crucial to provide feasible, lifesaving equipment and supplies for LMIC settings.

Additionally, a mother-baby dyad approach is needed to ensure zero separation, promoting bonding, family participatory care, and optimal feeding with mother's milk. Investments in systems, policy, and infrastructure must support this approach.

Why was it crucial to develop a solution to improve feeding mechanisms for these vulnerable infants?

WHO recommends that small and sick newborns receive mother's milk as the evidence-based priority feeding option for providing immunological and nutritional protection for these highly vulnerable infants. However, for babies born prematurely especially, their ability to feed directly at the breast is often not possible in those first hours, days or weeks of life because they are developmentally delayed and physically unable to suckle. Their suck-swallow-breath mechanism is not yet fully developed so until then they need supplemental feeding. In high-income settings this could be nasogastric tubes, specialized bottles, and breast pumps but these are often not feasible or available in LMIC settings. 

In low-resource areas, WHO recommends the use of a feeding cup, but at the time, there wasn’t a specialized feeding cup designed specifically for infants with special needs. Thus, the Nifty Cup - The Neonatal Intuitive Feeding Technology - was developed to meet this need.

What are the most significant challenges for feeding SSNs?

The feeding challenges that SSNs and their mothers face are numerous. Mothers of SSNs often struggle to breastfeed directly at the breast. Lactation initiation and milk supply (lactogenesis) are significantly impacted by pre-term labor and birth complications. Too often SSNs do not receive mothers’ own milk in a timely manner or sufficient volumes, setting off a cascade of alternative feeds and the potential for negative health outcomes.  

We have seen a lack of prioritizing innovation and market access for all supplies and equipment needed to optimize feeding of human milk and support for lactation – this includes even basic feeding cups and breast pumps as well as other supplies. Positioning these feeding supplies as a bundle and as an essential component in newborn care would facilitate ease in distribution and recognition of the critical role human milk plays in the survival of SSNs.

How did PATH collaborate with LGH to develop a low-cost, effective feeding solution?

This is an amazing story of collaboration. PATH worked with the Craniofacial Center at Seattle Children’s Hospital and the University of Washington School of Dentistry on product design, usability, feasibility, and validation testing.

The final development of the Nifty Cup had unique key features:

  • Extended reservoir off the lip of the cup that holds a small bowl of milk, ensuring efficient delivery of milk that mimics traditional breastfeeding where the infant can pace feeding.
  • Mothers can directly express breastmilk into the 60-ml cup, reducing possible cross-contamination from other containers.
  • Made of a durable, soft silicone material that protects the infant’s mouth from injury.
  • Embossed measurements to track the volume and intake of milk.
  • Ergonomically designed for frequent use and to enhance finger and wrist control over milk flow.
  • Quick-drying, UV-resistant, affordable silicone that can be boiled for sterilization.

Laerdal Global Health (LGH) was the perfect partner due to their significant experience producing high-volume, low-cost, high-quality molded silicone medical products. LGH would extend this expertise to manufacturing and distributing the Nifty Feeding Cup as a tool to complement their essential newborn care and small baby training programs for low-resource settings. After 5 years of user-focused design, PATH and Laerdal Global Health announced a partnership that would bring the Nifty Cup to market, enabling access around the world. This was a critical step to ensure the Nifty Cup would move beyond innovation and into the hands of the caregivers who need it. 

Is there any research evidence to support the effectiveness of the solution?

Yes, one study compared Nifty Cup to the paladai cup, a cup-like utensil popular in India. Results suggested that Nifty Cup was preferred by healthcare workers due to improvements in spillage, regurgitation, ease of use, and duration of feeding compared to the paladai. Additionally, a randomized control trial (RCT) in Ghana explored mothers’ preferences between Nifty Cup and a standard medicine cup. The Nifty Cup was found to be the preferred feeding method; mothers could use it with greater ease and confidence. Another RCT compared Nifty Cup with the Katori-spoon feeding in preterm neonates deemed fit for oral feeding; results suggest that the Nifty Cup helps in attaining full breastfeeds earlier than the Katori-spoon. I think the Nifty Cup should be in every NICU, it’s one of the best kept secrets for successful feeding of small and sick newborns.

How do partnerships and collaboration enhance the effectiveness of your initiatives?

Our work is successful only because of the partnerships we forge. Through partnerships with Ministries of Health and the healthcare workers we serve, we gain an accurate understanding of the needs and gaps as well as how to shape solutions, so they are feasible and sustainable. 

Through partnerships with organizations like Laerdal Global Health, we ensure these lifesaving innovations are manufactured with quality and safety, are ethically marketed, are costed to ensure access and ultimately used by those who need them most. PATH has a longstanding, trusted partnership with Laerdal Global Health to ensure that the innovations we develop together with our country teams, go beyond our product development and are transformed into market-ready, low-cost, accessible resources that save lives. 

What is the potential for large-scale impact?

Focusing on feeding and lactation for SSNs could be significant in reducing neonatal mortality. The challenges in ensuring access to human milk for SSN have been a ‘hidden’ issue, compounded by nutrition and newborn divisions in programming and funding. If a comprehensive approach to ensuring exclusive human milk diets were prioritized, the improvements in the health outcomes of SSNs would be seen both in the short-term during admission and also extending beyond discharge as care shifts to the home. Such a comprehensive model would include specialized lactation support targeting mothers of SSN special lactation needs, zero separation of mother/baby, provision of feeding supplies (Nifty Cup/feeding cups, breast pumps, storage), donor human milk from a locally appropriate human milk bank, and extended follow-up care to support feeding and lactation before challenges arise. The Nifty Cup plays a key role within this broader package of care. 

Too often I am in neonate wards where the healthcare workers see the value in using a Nifty Cup, but they just do not have them. We hope to work together to better understand these access gaps and strive to ensure global access is a reality.