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Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding
NA trial testing Nifty feeding cup in Infant,Premature in 200 participants. Completed in 25 September 2018.
| Lead sponsor | PATH |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | other |
| Enrollment | 200 |
| Start date | 15 August 2017 |
| Primary completion | 25 September 2018 |
| Estimated completion | 25 September 2018 |
| Sites | 1 location across Ghana |
PATH — full company profile →
18 and older, any sex, with Infant,Premature or Feeding; Difficult, Newborn. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| NIFTY Feeding Cup First | 82 | |
| Generic Medicine Cup First | 67 |
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.
| Group | Value | 95% CI |
|---|---|---|
| NIFTY Feeding Cup First | 8.9 | ± 6.9 |
| Generic Medicine Cup First | 9.3 | ± 8.7 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing