Coffey: The NIFTY™ Cup

7/28/2019 Coffey: The NIFTY Cup

1/19

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


2/19

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.


3/19

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.

4/16/2013Page 3


4/19

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


5/19

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


6/19

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:


7/19

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


8/19

Initial Concepts and Work

Develop product

specification and initialmodels to test feasibility ofthat specification.

4oz volume. Easy to hold.

Opening size for

manual expression.


9/19

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.

4/16/2013Page 9

Foley cup:

Paladai:

Hygeia Expression Cup:

Medela feeding cup:


10/19

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


11/19

4oz Asymmetrical Design

Final conclusion is that a symmetrical

design is preferable.


12/19

3oz NIFTY Cup


13/19

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


14/19

NIFTY Cup Prototype Development

Trajectory

4/16/2013Page 14

Current NIFTY prototype


15/19

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.

4/16/2013Page 15


16/19

Pictorial Instructions


17/19

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.

4/16/2013Page 17


18/19

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)

4/16/2013Page 18

Development

Validation

Regulatory

Introduction

Scale

- implement

test marketstrategies for

distribution

and sales


19/19

Comments?

Questions?

4/16/2013Page 19

THANK YOU

For more information, please contact

Patricia Coffey ([email protected])

Coffey: The NIFTY™ Cup

Documents

Transcript of Coffey: The NIFTY™ Cup