Collins 2004.

Methods	Parallel‐group randomised controlled trial
Participants	Participants: preterm infants Birth weight: 1325 grams ‐ 1508 grams Mean gestational age: 23‐33 weeks Mean postnatal age: not reported Setting: 2 large tertiary hospitals, 54 peripheral hospitals, Australlia Inclusion criteria: women with singleton or twin infants < 34 weeks' gestation who wanted to breast feed Exclusion criteria: infants with congenital abnormalities precluding enteral feeding
Interventions	Experimental group: bottle or cup and pacifier ‐ cup or bottle feeding commenced at the discretion of the attending nurse/midwife or neonatologist and occurred when the mother was unavailable to breast feed or when additional milk, given orally, was required after a breast feed. Small plastic medicine cups were used. Infants randomised to NNS groups had dummies available on trial entry; their use was encouraged during tube feeds and when the infant was restless. Control: bottle or cup and no pacifier ‐ for infants who did not receive NNS, alternate soothing methods were promoted (for example, facilitation of hand‐to‐mouth action promoting self‐quieting behavior).
Outcomes	Proportion of infants fully breastfeeding (compared with partially and not). Full breastfeeding meant that no other types of milk or solids were given except vitamins or minerals. Proportion of infants receiving any breastfeeding (compared with none) on discharge home. Length of hospital stay Prevalence of breastfeeding at 3 and 6 months after discharge Note: breastfeeding defined as mother's milk given by direct breastfeeding or other feeding device.
Notes	Non‐adherence: of the infants randomised to cup feeding, 56% (85/151) had a bottle introduced, and of the infants randomised to no dummy, 31% (47/152) had a dummy introduced. Reasons dummies were introduced were: baby was unsettled (37%, 14/38) and to teach the baby to suck (29%, 11/38). Data analysed as intention‐to‐treat.
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 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. Researchers determined allocation by telephoning an independent ward, available 24 hours a day, within the recruiting hospitals.
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	16 infants excluded ‐ cup or bottle and NNS (n = 6), cup or bottle and no NNS (n = 10). Reasons given for attrition.
Selective reporting (reporting bias)	Low risk	Reporting of outcomes same as protocol