Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding (NCT03280381) | Clinical Trial Compass
CompletedNot Applicable
Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding
Ghana200 participantsStarted 2017-08-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.