NCT03280381

Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Infant,Premature
• Feeding; Difficult, Newborn

Interventions

Type	Name	Description
OTHER	Nifty feeding cup	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.
OTHER	Generic medicine cup	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.

Timeline

• Start date: 2017-08-15
• Primary completion: 2018-09-25
• Completion: 2018-09-25
• First posted: 2017-09-12
• Last updated: 2019-08-08
• Results posted: 2019-08-08

Locations

1 site across 1 country: Ghana