Clinical trial NCT03280381: Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding
Official title: Randomized Crossover Trial of the Nifty Feeding Cup and a Medicine Cup in Preterm Infants Who Have Difficulty Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant,Premature
Feeding; Difficult, Newborn
Keywords: Nifty Cup
breastfeeding difficulties
preterm infant
cup feeding
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
name: Komfo Anokye Teaching Hospital
First posted: 2017-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Investigators will conduct a randomized crossover trial in mothers/caregivers with a preterm infant in the mother-baby unit at Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana. Each caregiver/infant pair will use the Nifty Feeding Cup for two feeds and the standardized generic cup for two feeds. Cross-over means each caregiver/infant pair will use both cups, with the order of the cup used first and second randomized.
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Caregiver Satisfaction [Immediate]
timeFrame: 24-36 hours
measure: Spillage
timeFrame: 24-36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kumasi
country: Ghana
facility: Komfo Anokye Teaching Hospital (KATH)
Study officials:
affiliation: Seattle Children's Hospital
name: Christy McKinney, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: