CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Nifty feeding cup +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03280381
NCT03280381N/ACompleted

Randomized Crossover Trial of the Nifty Feeding Cup and a Medicine Cup in Preterm Infants Who Have Difficulty Breastfeeding

PATH·interventional·Posted Sep 12, 2017·Updated Aug 8, 2019

In Brief

A clinical study evaluating Nifty feeding cup and Generic medicine cup for Infant,Premature and Feeding; Difficult, Newborn. Completed, enrolled 200 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGhana

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 12, 2017
Enrollment StartAug 15, 2017
Primary CompletionSep 25, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.8 years ago

Interventions

Nifty feeding cupother

The 40 mL Nifty Feeding Cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, ensuring efficient delivery of milk, is made of a durable, soft, silicone material that protects the infant's mouth from injury, has embossed measurements help with tracking volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.

Generic medicine cupother

The generic cup that will be used in this study is a small medicine cup 30 ml in size.Small medicine cups are manufactured by a variety of manufacturers and are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties. The cups are generally translucent, calibrated with a variety of measurements including 2.5-30 mL.