Mosley 2001.
| Methods | Randomised controlled trial, pilot study. Study duration ‐ 3 months | |
| Participants | Single centre, Special Care Baby Unit, District General Hospital, England Inclusion criteria: gestational age 32 to 37 weeks, mother wishes to breast feed, no congenital abnormality, no maternal preference for cup or bottle, infant had not been fed by cup or bottle Experimental group: mean gestational age 35.5 weeks, SD not reported; control group: 35.2 weeks, SD not reported Sample size: 16 randomised (8 experimental/cup, 8 control/bottle); 14 included in analysis (6 experimental/cup, 8 control/bottle) |
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| Interventions | Experimental: supplementary feeds given by cup Control: supplementary feeds given by bottle |
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| Outcomes | Prevalence exclusive breast feeding on discharge home | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "There were 10 instructions to cup feed and ten to bottle feed. These details were then put in the envelopes, shuffled thoroughly and then the envelopes were numbered sequentially". |
| Allocation concealment (selection bias) | Low risk | Quote: "Midwife/nurse responsible was asked to select a sealed, numbered, opaque envelope, which contained information on the feeding method to be adopted". |
| Blinding (performance bias and detection bias) All outcomes | High risk | Not possible to blind intervention. No information provided on blinding of outcome assessors |
| Incomplete outcome data (attrition bias) On discharge home | Low risk | Missing outcome data (n = 2, 13%) (experimental 2, control 0):
Comment: Although difference in proportion of incomplete outcome data was noted across groups (25% experimental, 0% control), the sample size was so small that we are unable to sensibly assess the impact of missing data. Low risk of bias due to incomplete outcome data |
| Selective reporting (reporting bias) | Low risk | Before clinical trial registration requirements, all expected outcomes reported |
| Other bias | Low risk | Nil noted |