NCT03280381

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 8, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

September 6, 2017

Results QC Date

June 12, 2019

Last Update Submit

August 7, 2019

Conditions

Infant,PrematureFeeding; Difficult, Newborn

Keywords

Nifty Cupbreastfeeding difficultiespreterm infantcup feeding

Outcome Measures

Primary Outcomes (2)

  • Caregiver Satisfaction [Immediate]

    Caregiver's satisfaction will be the cup she prefers, which will be recorded in the In-Hospital Preference Survey completed after the caregiver has finished the feeding portion of the study. Data refers to number of caregivers who prefer the Nifty Cup.

    24-36 hours

  • Spillage

    Spillage will be reported as a percent with the amount of milk in grams spilled/mopped up divided by the total amount of milk weighed in grams less the total amount of milk not used. Each caregiver-infant pair will be provided with a bib cloth for each observed feeding. The bib cloth will be weighed before and after each feed and the weights recorded on the Feeding Assessment form. The difference between the pre and post weights will be used as the measure of the amount spilled. A digital scale will be used to measure the milk weight, which will be recorded in grams.

    24-36 hours

Study Arms (2)

NIFTY Feeding Cup First

EXPERIMENTAL

Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.

Other: Nifty feeding cupOther: Generic medicine cup

Generic Medicine Cup First

EXPERIMENTAL

Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.

Other: Nifty feeding cupOther: Generic medicine cup

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 Cup FirstNIFTY Feeding Cup First
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.

Generic Medicine Cup FirstNIFTY Feeding Cup First

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Komfo Anokye Teaching Hospital (KATH)

Kumasi, Ghana

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Results Point of Contact

Title
Dr. Patricia S. Coffey
Organization
PATH
pcoffey@path.org
206-302-4704

Study Officials

  • Christy McKinney, Ph.D.

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Investigators will conduct a randomized crossover trial in mothers/caregivers with a preterm infant in the mother-baby unit at Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana. Each caregiver/infant pair will use the Nifty Feeding Cup for two feeds and the standardized generic cup for two feeds. Cross-over means each caregiver/infant pair will use both cups, with the order of the cup used first and second randomized.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 12, 2017

Study Start

August 15, 2017

Primary Completion

September 25, 2018

Study Completion

September 25, 2018

Last Updated

August 8, 2019

Results First Posted

August 8, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

GH(1)