Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding

Not Applicable

Completed

Brief Summary: The investigators will establish an evidence base for the Nifty Feeding Cup by evaluating its effectiveness and caregiver satisfaction. The investigators will conduct a randomized crossover trial that compares the Nifty Feeding Cup to a standardized, generic medicine cup used to feed preterm infants with breastfeeding difficulties at Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana.

Detailed Description: The investigators aim to compare the Nifty Feeding Cup to a standardized, generic cup in up to 200 preterm infants. The aim and hypotheses were selected based on the most informative outcomes given the scope of the funding. The investigators will test the hypotheses that Nifty Feeding Cup feeding compared to generic cup feeding will result in:

1. Less spillage

2. Greater caregiver satisfaction

3. Shorter duration of feeds

Recruitment & Eligibility

Inclusion Criteria

Infant

Born preterm (<37 weeks gestational age) at time of birth
Corrected gestational age is <37 weeks per the modified Dubowitz score on date of enrollment
Diagnosed with feeding difficulties
Patient in the mother-baby unit at KATH
Clinically indicated to start cup feeding (including an infant who has a nasogastric tube and is cup feeding or indicated to start cup feeding)
Has an anticipated hospital stay that is at least 48 hours

Caregiver:

At least 18 years of age
One of the following biologic family members of the infant (Mother, Grandmother, Aunt)
Self-identifies as the primary feeder of the infant
Prior experience feeding the potential infant participant with nipple feeding (e.g. breast feeding, bottle feeding) or nasogastric [NG] tube
Verifies willingness to comply with all study procedures

Exclusion Criteria

Infant

Congenital anomaly except for minor anomalies (e.g. an extra digit or ear tag is okay)
Other condition or situation that makes infant unlikely to be able to comply with study procedures. Examples include the infant anticipated to not be in hospital long enough, infant has a suspected intestinal obstruction, or necrotizing enterocolitis.
No mother, grandmother, or aunt caregiver available to participate in study
Enrolled in another study at KATH that would interfere with his/her ability to participate in this study.

Arm && Interventions

Group	Intervention	Description
NIFTY Feeding Cup First	Generic medicine cup	Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.
Generic Medicine Cup First	Generic medicine cup	Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.
Generic Medicine Cup First	Nifty feeding cup	Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.
NIFTY Feeding Cup First	Nifty feeding cup	Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.

Primary Outcome Measures

Name	Time	Method
Caregiver Satisfaction [Immediate]	24-36 hours	Caregiver's satisfaction will be the cup she prefers, which will be recorded in the In-Hospital Preference Survey completed after the caregiver has finished the feeding portion of the study. Data refers to number of caregivers who prefer the Nifty Cup.
Spillage	24-36 hours	Spillage will be reported as a percent with the amount of milk in grams spilled/mopped up divided by the total amount of milk weighed in grams less the total amount of milk not used. Each caregiver-infant pair will be provided with a bib cloth for each observed feeding. The bib cloth will be weighed before and after each feed and the weights recorded on the Feeding Assessment form. The difference between the pre and post weights will be used as the measure of the amount spilled. A digital scale will be used to measure the milk weight, which will be recorded in grams.

Secondary Outcome Measures