coffey: the nifty™ cup
TRANSCRIPT
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Patricia S. Coffey, PhD, MPH
Johannesburg, South Africa
April 16, 2013
THE NEONATAL INTUITIVE FEEDING
TECHNOLOGY (NIFTY
) CUP
Photo: PATH/Amy MacIver
Co-authors:
Christy McKinney
Michael Cunningham
Peter Donkor
Jered Singleton
Robin Glass
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Infants Unable to Breastfeed
Preterm infants
15 million born globally each year.
Coordinated suck, swallow, and breathe is
undeveloped.
Assistive feeding until exclusive breastfeeding.
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.
90% of infants with clefts/anomolies are born in low-
resource settings.
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Policy Environment
Extra support forfeeding small andpreterm babies includesfeeding cups as keycommodity.
WHO guidelines on optimalfeeding of LBW infants inLMIC
LBW infants who needto be fed by an
alternative oral feedingmethod should be fedby cup, paladai (a cupwith a beak), or spoon.
Strong recommendationwith moderateevidence.
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Standard of Care
High-resource settings
Enteral feeding.
Breast pump milk or storedbreast milk.
Fed with (specialized) bottles.
Low-resource settings
Enteral feeding (maybe) then
Manual expression of breastmilk as needed.
Fed with conventional, locally
available cup (or spoon).
Photo: WHO
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Conventional Cups
Benefits
Any available cup can be used; no standard.
Widely available.
Infant only needs to be able to swallow.
Inexpensive.
Limitations
Rate of flow difficult to control.
Choking and aspirating common.
Energy depleting: intake less than energyexpended.
May increase infection risk (e.g., multiple users).
Photo: WHO
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Beyond Conventional Cups
Foley cup is useful, but not ideal for low-
resource settings
Mothers and clinicians find it more effective.
Too small to capture hand expressed breast milk.
Durability, cleanability, and material cost not
appropriate.
Paladai
Used often in India.
Pour into infants mouth, increased risk ofaspiration/choking because infant notparticipating in pace of feeding.
Less control (for mother and infant).
Foley cup:
Paladai:
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Essence of Our Idea
Objective:
To design and validate an improved device for delivery ofexpressed breast milk to infants unable to breastfeed in low-resource 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
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Initial Concepts and Work
Develop product
specification and initialmodels to test feasibility ofthat specification.
4oz volume. Easy to hold.
Opening size for
manual expression.
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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.
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Foley cup:
Paladai:
Hygeia Expression Cup:
Medela feeding cup:
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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)
Material
Elastic and pliable (75 to 85 Shore A)
Food grade
Translucent
Cleaning = boil, autoclave, bleach and Cidex resistant
Marked with metric and SI units
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4oz Asymmetrical Design
Final conclusion is that a symmetrical
design is preferable.
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3oz NIFTY Cup
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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
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NIFTY Cup Prototype Development
Trajectory
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Current NIFTY prototype
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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.
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Pictorial Instructions
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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.
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Product and Market Development Next Steps
- feasibility and
acceptabilityby end-users(India, Ghana)
- clinical trialto assesseffectiveness
- negotiatedeal withinterestedpartner (USA)that is CE and
ISO certifiedmanufacturer
- marketassessment inkey targetmarkets(Ghana, India)
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Development
Validation
Regulatory
Introduction
Scale
- implement
test marketstrategies for
distribution
and sales
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Comments?
Questions?
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THANK YOU
For more information, please contact
Patricia Coffey ([email protected])