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

NCT03280381 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-08-08

Study results available
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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.

Conditions

  • Infant,Premature
  • Feeding; Difficult, Newborn

Interventions

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.

Sponsors & Collaborators

  • Seattle Children's Hospital

    collaborator OTHER

  • Komfo Anokye Teaching Hospital

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • Christy McKinney, Ph.D. · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-15
Primary Completion
2018-09-25
Completion
2018-09-25

Countries

  • Ghana

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03280381 on ClinicalTrials.gov