Trial Outcomes & Findings for Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding (NCT NCT03280381)
NCT ID: NCT03280381
Last Updated: 2019-08-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
24-36 hours
Results posted on
2019-08-08
Participant Flow
Participant milestones
| Measure |
NIFTY Feeding Cup First
Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track 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 and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.
|
Generic Medicine Cup First
Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track 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 and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
99
|
|
Overall Study
COMPLETED
|
101
|
97
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
NIFTY Feeding Cup First
Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track 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 and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.
|
Generic Medicine Cup First
Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track 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 and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Baseline demographic data
Baseline characteristics by cohort
| Measure |
NIFTY Feeding Cup First
n=101 Participants
Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track 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 and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.
|
Generic Medicine Cup First
n=99 Participants
Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track 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 and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=101 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=200 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
101 Participants
n=101 Participants
|
99 Participants
n=99 Participants
|
200 Participants
n=200 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=101 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=200 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=101 Participants • Baseline demographic data
|
99 Participants
n=99 Participants • Baseline demographic data
|
200 Participants
n=200 Participants • Baseline demographic data
|
|
Sex: Female, Male
Male
|
0 Participants
n=101 Participants • Baseline demographic data
|
0 Participants
n=99 Participants • Baseline demographic data
|
0 Participants
n=200 Participants • Baseline demographic data
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 24-36 hoursCaregiver'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.
Outcome measures
| Measure |
NIFTY Feeding Cup First
n=101 Participants
Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track 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 and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.
|
Generic Medicine Cup First
n=97 Participants
Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track 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 and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.
|
|---|---|---|
|
Caregiver Satisfaction [Immediate]
|
82 participants
|
67 participants
|
PRIMARY outcome
Timeframe: 24-36 hoursSpillage 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.
Outcome measures
| Measure |
NIFTY Feeding Cup First
n=101 Participants
Each caregiver/infant pair will first use the Nifty Feeding Cup for two feeds and then the standardized generic cup for two feeds.
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track 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 and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.
|
Generic Medicine Cup First
n=97 Participants
Each caregiver/infant pair will first use the standardized generic cup for two feeds and then the Nifty Feeding Cup for two feeds.
Nifty Feeding Cup: The 40 mL cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, has embossed measurements to track 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 and soft silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.
Generic medicine cup: A generic 30 mL small medicine cup was used in this study. Small medicine cups are manufactured by many manufacturers and are generally translucent and calibrated with a variety of measurements. They are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties.
|
|---|---|---|
|
Spillage
|
8.9 percentage of feed spilled
Standard Deviation 6.9
|
9.3 percentage of feed spilled
Standard Deviation 8.7
|
Adverse Events
NIFTY Feeding Cup First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Generic Medicine Cup First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place