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

PATH

Status: Completed

Conditions: Feeding; Difficult, Newborn; Infant,Premature

Treatments: Other: Nifty feeding cup; Other: Generic medicine cup

Study type: Interventional

Funder types: Other

Identifiers

NCT03280381

978912-3

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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200 participants in 2 patient groups

NIFTY Feeding Cup First

Experimental group

Description:

Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.

Treatment:

Other: Generic medicine cup

Other: Nifty feeding cup

Generic Medicine Cup First

Experimental group

Description:

Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.

Treatment:

Other: Generic medicine cup

Other: Nifty feeding cup