N/A
Completed N=200
Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding
Infant,Premature · Feeding; Difficult, Newborn
Source: ClinicalTrials.gov NCT03280381 ↗
Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Caregiver Satisfaction [Immediate] — 82; 67 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Caregiver Satisfaction [Immediate] |
82; 67 | — |
| PRIMARY Spillage |
8.9; 9.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03280381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.