| Methods |
Randomised Controlled Trial.
Allocation concealment (blinding of randomisation): yes
Blinding of intervention: no
Completeness of follow up: yes
Blinding of outcome measurement: no |
| Participants |
319 preterm infants randomised (cup‐feeding group n = 161; bottle‐feeding group n = 158) (mean gestational ages 29.3 and 30.0 weeks); conducted in Australia; involved 2 tertiary hospitals and 54 peripheral hospitals (this number of peripheral hospitals were involved as they were the receiving hospitals for the babies from the tertiary hospitals).
Eligibility criteria: preterm infants less than 34 weeks' gestational age whose mothers wanted to breastfeed. |
| Interventions |
Randomised to supplemental feeds via cup or bottle |
| Outcomes |
Not breastfeeding at hospital discharge: number assessed ‐ cup‐feeding group N = 151; bottle‐feeding group N = 152.
Not breastfeeding at 3 months: number assessed ‐ cup‐feeding group N = 144; bottle‐feeding group N = 139
Not breastfeeding at 6 months: number assessed ‐ cup‐feeding group N = 142; bottle‐feeding group N = 139
Not fully breastfeeding at hospital discharge: number assessed ‐ cup‐feeding group N = 151; bottle‐feeding group N = 152
Not fully breastfeeding at 3 months: number assessed ‐ cup‐feeding group N = 144; bottle‐feeding group N = 139
Not fully breastfeeding at 6 months: number assessed ‐ cup‐feeding group N = 142; bottle‐feeding group N = 139
Length of hospital stay: number assessed ‐ cup‐feeding group N = 149; bottle‐feeding group N = 152 |
| Notes |
Results are an evaluation of infants followed at 3 and 6 months and not all infants randomised |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"an independent researcher developed a separate randomisation schedule for each recruiting hospital by using a random number table to select balanced blocks of varying size with stratification for gestation" |
| Allocation concealment (selection bias) |
Low risk |
"assignments were sealed in sequentially numbered opaque envelopes" |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Due to the nature of the intervention, participants and personnel cannot be blinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
"data entry and analysis were undertaken unblinded" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
|
| Selective reporting (reporting bias) |
Low risk |
All outcomes reported |
