Status:
COMPLETED
Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding
Lead Sponsor:
PATH
Collaborating Sponsors:
Seattle Children's Hospital
Komfo Anokye Teaching Hospital
Conditions:
Infant,Premature
Feeding; Difficult, Newborn
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2018
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03280381
Start Date
August 15 2017
End Date
September 25 2018
Last Update
August 8 2019
Active Locations (1)
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1
Komfo Anokye Teaching Hospital (KATH)
Kumasi, Ghana