You are on page 1of 19


Patricia S. Coffey, PhD, MPH Johannesburg, South Africa April 16, 2013
Co-authors: Christy McKinney Michael Cunningham Peter Donkor Jered Singleton Robin Glass

Photo: PATH/Amy MacIver

Infants Unable to Breastfeed

Preterm infants

15 million born globally each year. Coordinated suck, swallow, and breathe is undeveloped. Assistive feeding until exclusive breastfeeding.

90% of infants with clefts/ anomolies are born in lowresource settings.

Infants with cleft palate (w&w/out cleft lip)

Anatomic abnormality/inability to suck and extract milk. Long-term assistance required.

Health and growth needed for surgical repair.

Other infants

Orphaned infants Respiratory and cardiac anomalies; neurologic or physical impairment.

Policy Environment

WHO guidelines on optimal feeding of LBW infants in LMIC

Extra support for feeding small and preterm babies includes feeding cups as key commodity.

LBW infants who need to be fed by an alternative oral feeding method should be fed by cup, paladai (a cup with a beak), or spoon. Strong recommendation with moderate evidence.

Page 3

Standard of Care
High-resource settings

Low-resource settings

Enteral feeding. Breast pump milk or stored breast milk. Fed with (specialized) bottles.

Enteral feeding (maybe) then Manual expression of breast milk as needed. Fed with conventional, locally available cup (or spoon).

Photo: WHO

Conventional Cups

Any available cup can be used; no standard.

Widely available. Infant only needs to be able to swallow.



Rate of flow difficult to control.

Choking and aspirating common. Energy depleting: intake less than energy expended.
Photo: WHO

May increase infection risk (e.g., multiple users).

Beyond Conventional Cups

Foley cup:

Foley cup is useful, but not ideal for lowresource settings

Mothers and clinicians find it more effective. Too small to capture hand expressed breast milk.

Durability, cleanability, and material cost not appropriate.


Used often in India. Pour into infants mouth, increased risk of aspiration/choking because infant not participating in pace of feeding. Less control (for mother and infant).


Essence of Our Idea

Objective: To design and validate an improved device for delivery of expressed breast milk to infants unable to breastfeed in lowresource settings. The NIFTY cup will be: Highly efficient. Simple and intuitive. Safe. Durable (1-year). Easy to clean. Low cost.

Courtesy of Journal of Young Investigators

Initial Concepts and Work

Develop product specification and initial models to test feasibility of that specification.

4oz volume.

Easy to hold.
Opening size for manual expression.

Qualitative Assessment of Existing Cups

Too small for hand expression of breast milk. Too small for older infants. Not designed for optimal feeding efficiency. Metal increases risk of cutting infants mouth. Multiple parts increase risk of infection.

Hygeia Expression Cup:

Foley cup:

Medela feeding cup:


Page 9


Specification (highlights) Revised Jan 2012

Cost of Goods (includes packaging) $.90 max Top opening diameter = 60mm to 100ml Max volume = 2oz to 3oz (88ml to 118ml)


Elastic and pliable (75 to 85 Shore A) Food grade Translucent

Cleaning = boil, autoclave, bleach and Cidex resistant

Marked with metric and SI units

4oz Asymmetrical Design

Final conclusion is that a symmetrical design is preferable.

3oz NIFTY Cup

2oz NIFTY Cup (Final)

Further feedback suggested that an even smaller cup may be ideal. This is a 2oz design.

2oz Designed in December 2011

NIFTY Cup Prototype Development Trajectory

Current NIFTY prototype

Page 14 4/16/2013

NIFTY Cup Prototype Specifications

Easy to hold for extended periods. Minimal, smooth grooves to lessen the risk of infection. Easy flow-rate control.

Decreased spillage.
Big enough for hand expression. Size: 2oz/60ml. Volume markers on cup. Pictorial instructions included.

Page 15


Pictorial Instructions

Evidence Generation (unfunded)

Survey: current practices and NIFTY prototype feedback

Mothers/end-users and health care workers. Designed to assess demand and pricing.

Intervention case-crossover study

Mother-infant pairs with cleft palate. NIFTY vs. standard of care cup Assess volume, feeding time, and mother preference.

Randomized case-crossover clinical trial

Preterm hospitalized infants.

NIFTY vs. standard of care cup, randomized order.

Assess volume, feeding time, and mother preference.

Page 17


Product and Market Development Next Steps

Introduction Regulatory Validation Development - feasibility and acceptability by end-users (India, Ghana) - clinical trial to assess effectiveness - negotiate deal with interested partner (USA) that is CE and ISO certified manufacturer - market assessment in key target markets (Ghana, India)

- implement test market strategies for distribution and sales

Page 18


THANK YOU Comments? Questions?

For more information, please contact Patricia Coffey (

Page 19 4/16/2013