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

Primary Purpose

Infant,Premature, Feeding; Difficult, Newborn

Status

Completed

Phase

Not Applicable

Locations

Ghana

Study Type

Interventional

Intervention

Nifty feeding cup

Generic medicine cup

About this trial

This is an interventional other trial for Infant,Premature focused on measuring Nifty Cup, breastfeeding difficulties, preterm infant, cup feeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Komfo Anokye Teaching Hospital (KATH)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

NIFTY Feeding Cup First

Generic Medicine Cup First

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03280381

First Posted

September 6, 2017

Last Updated

August 7, 2019

Sponsor

PATH

Collaborators

Seattle Children's Hospital, Komfo Anokye Teaching Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03280381

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

August 15, 2017 (Actual)

Primary Completion Date

September 25, 2018 (Actual)

Study Completion Date

September 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PATH

Collaborators

Seattle Children's Hospital, Komfo Anokye Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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: Less spillage Greater caregiver satisfaction Shorter duration of feeds

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infant,Premature, Feeding; Difficult, Newborn

Keywords

Nifty Cup, breastfeeding difficulties, preterm infant, cup feeding

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

Investigator

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NIFTY Feeding Cup First

Arm Type

Experimental

Arm Description

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

Arm Title

Generic Medicine Cup First

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Nifty feeding cup

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Generic medicine cup

Intervention Description

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.

Primary Outcome Measure Information:

Title

Caregiver Satisfaction [Immediate]

Description

Time Frame

24-36 hours

Title

Spillage

Description

Time Frame

24-36 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christy McKinney, Ph.D.

Organizational Affiliation

Seattle Children's

Official's Role

Principal Investigator

Facility Information:

Facility Name

Komfo Anokye Teaching Hospital (KATH)

City

Kumasi

Country

Ghana

12. IPD Sharing Statement

Plan to Share IPD

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

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