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| Name | Class |
|---|---|
| Seattle Children's Hospital | OTHER |
| Komfo Anokye Teaching Hospital | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifty feeding cup | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Infant
Caregiver:
Exclusion Criteria:
Infant
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| Name | Affiliation | Role |
|---|---|---|
| Christy McKinney, Ph.D. | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Komfo Anokye Teaching Hospital (KATH) | Kumasi | Ghana |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 24-36 hours |
|
Data were collected over the time it took mothers to feed their infants twice with each cup, an average of 13 minutes per feed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patricia S. Coffey | PATH | 206-302-4704 | pcoffey@path.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2019 | Feb 22, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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| Generic medicine cup | Other | 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. |
|
| BG001 | Generic Medicine 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Baseline demographic data | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | 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. |
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of feed spilled | 24-36 hours |
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| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | 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. | 0 | 99 | 0 | 99 | 0 | 99 |
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| D000091642 | Urogenital Diseases |