Feeding; Difficult, Newborn, Infant,Premature
Conditions
Keywords
Nifty Cup, breastfeeding difficulties, preterm infant, cup feeding
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: 1. Less spillage 2. Greater caregiver satisfaction 3. Shorter duration of feeds
Interventions
OTHERNifty 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.
OTHERGeneric 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
Seattle Children's Hospital
Komfo Anokye Teaching Hospital
PATH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Satisfaction [Immediate] | 24-36 hours | 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 | 24-36 hours | 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. |
Countries
Ghana
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 101 |
| 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. | 99 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 2 |
Baseline characteristics
| Characteristic | NIFTY Feeding Cup First | Generic Medicine Cup First | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 101 Participants | 99 Participants | 200 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 101 Participants | 99 Participants | 200 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 99 |
| other Total, other adverse events | 0 / 101 | 0 / 99 |
| serious Total, serious adverse events | 0 / 101 | 0 / 99 |
Outcome results
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.
Time frame: 24-36 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NIFTY Feeding Cup First | Caregiver Satisfaction [Immediate] | 82 participants |
| Generic Medicine Cup First | Caregiver Satisfaction [Immediate] | 67 participants |
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.
Time frame: 24-36 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NIFTY Feeding Cup First | Spillage | 8.9 percentage of feed spilled | Standard Deviation 6.9 |
| Generic Medicine Cup First | Spillage | 9.3 percentage of feed spilled | Standard Deviation 8.7 |