Fucile 2002.

Methods	Country: USA RCT Random sequence generation: stratified random sampling technique used to ensure that groups were similar in mean gestational age and birth weight Allocation concealment unclear No blinding of personnel delivering the intervention. Researchers carried out both treatment and sham treatments. Caregivers and family blinded to intervention Blinding of outcome assessors unclear Treatment duration: 10 consecutive days
Participants	32 participants in total: 19 females, 13 males 16 participants in each group Treatment group: N = 16, age range 28 ± 1.3 weeks, GA 26.4 to 29.9 weeks, birth weight 1044 ± 260 (740 to 1500) grams Control group: N = 16, age range 28.1 ± 1.1 weeks, GA 26.0 to 29.7 weeks, birth weight 959 ± 244 (560 to 1300) grams
Interventions	Nursing and medical staff were reported to be blinded to the intervention, as a screen was placed around the isolette during any intervention. Both groups were monitored from time of entry into the study until discharge from the hospital. Initiation and advancement of oral feeding were left to the discretion of the attending physician and nurses who were responsible for standard feeding care. Measures were taken at the introduction of oral feeds, at 1 oral feed per day, at 4 oral feeds per day and at 8 oral feeds per day. Interventions were started 48 hours after discontinuation of nasal CPAP. Intervention was not administered if infants were disturbed 30 minutes before the intervention, and it was stopped if infants were medically unstable and/or had any episodes of oxygen desaturation and/or apnoea/bradycardia during the intervention. Treatment group received a prefeeding oral stimulation programme consisting of a 12‐minute finger stroking protocol, followed by 3 minutes of sucking on a pacifier. Intervention lasted 15 minutes and was performed once a day for 10 consecutive days, 15 to 30 minutes before a tube feeding. Control group received sham stimulation identical to the prefeeding stimulation programme, except that they did not receive the 15‐minute finger stroking and pacifier portion of the protocol.
Outcomes	Days to transition from complete tube feeding to independent oral feeds Days to 1 oral feed a day Days to 4 oral feeds a day % volume intake Rate of milk transfer (mL/min) Length of stay PMA and weight at both 1 to 2 oral feeds per day and 6 to 8 oral feeds per day Sucking pattern maturation Sucking frequency and amplitude Behavioural state before and after feeds, number of episodes of apnoea, bradycardia or oxygen desaturation
Notes	Both gestational age (GA) and postmenstrual age (PMA) are used in the report. GA is used to describe age at birth and age range of groups, PMA to describe age at feeding. Some adverse effects were reported in 1 case, in which bradycardia was observed but resolved spontaneously.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Infants were randomised into control or experimental groups in blocks of 4, stratified by gestational age (26 to 27 vs 28 to 29 weeks).
Allocation concealment (selection bias)	Unclear risk	This was not described.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Researchers carried out both treatments and sham treatments. Caregivers and family were blinded to intervention.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Advancement of oral feeding was done at the discretion of physicians, who were blinded to treatment allocation.
Incomplete outcome data (attrition bias) All outcomes	High risk	It is reported that groups were similar in baseline characteristics, such as number of infants who received breast feedings throughout the study, gastric residuals, oxygen requirement, episodes of oxygen desaturation and/or apnoea/bradycardia at the 3 monitored feeding sessions and behavioural state, although data are not provided to confirm.
Selective reporting (reporting bias)	High risk	Not all outcomes are fully reported as above.
Other bias	Unclear risk	Information provided was insufficient to permit judgement.