Fucile 2012.

Methods	Country: USA RCT Random sequence generation: infants randomised by stratified blocked randomisation Allocation concealment: no Blinding of personnel delivering the intervention: unclear Blinding of outcome assessors: unclear Treatment duration: 14 days
Participants	75 infants were enrolled: Group 1, O: N = 19 (12 male/7 female), age range 29.6 weeks GA (SEM 0.4), 10 were 26 to 29 weeks GA, 9 were 30 to 32 weeks GA, birth weight 1359.7 (78.2) grams Group 2, T/K: N = 18 (11 male/7 female), 8 were 26 to 29 weeks GA, 10 were 30 to 32 weeks GA, birth weight 1325.4 (53.3) grams Group 3, O + T/K: N = 18 (10 male/8 female), 11 were 26 to 29 weeks GA, 7 were 30 to 32 weeks GA, birth weight 1329.6 (39.1) grams Control group: N = 20 (16 male/4 female), 9 were 26 to 29 weeks GA, 11 were 30 to 32 weeks GA, birth weight 1346.6 (39.3) grams
Interventions	Group 1, oral (O): twice‐daily finger stroking protocol of the cheeks, lips, gums and tongue for 12 minutes and NNS for 3 minutes as per previously described protocol Group 2, T/K: twice‐daily stroking of the head, neck, back, arms and legs for 10 minutes and passive range of motion to the limbs for 5 minutes Group 3, O + T/K: 15 minutes of O or T/K, each once a day, in random order Control intervention: Researcher placed her hands in the incubator but did not touch the infant for 15 minutes twice daily. Assigned interventions were started 48 hours after discontinuation of nasal CPAP and were administered in two 15‐minute sessions/d for 10 days over a 14‐day period. Sessions were provided 30 minutes before tube feedings, with a minimum 3‐hour interval between sessions, to clinically stable infants. Interventions were stopped if adverse effects were observed. Participants were monitored from study start to hospital discharge. Nutritive sucking skills were assessed on a 5‐point stage of sucking scale, suck/swallow co‐ordination was assessed by a suck‐to‐swallow ratio and respiratory patterns were assessed with nipple‐bottle apparatus that simultaneously recorded suck, swallow and respiration. These measurements were monitored once during 3 oral feeding sessions, when infants were taking 1 to 2, 3 to 5 and 6 to 8 oral feedings per day. Management of feeding was left to the discretion of attending neonatologists. Nurses were responsible for standard feeding care.
Outcomes	Stage of sucking Stage of sucking at 1 to 2 oral feeds/d 3 to 5 oral feeds/d 6 to 8 oral feeds/d Suction amplitude Expression amplitude Suck/swallow co‐ordination Swallow/respiratory co‐ordination Pause‐swallow‐pause (P‐SW‐P) patterns Expire‐swallow‐expire (E‐SW‐E) patterns Also recorded were severity of illness, number of infants receiving all or partial breast feeding, number of co‐interventions (occupational/physical and/or speech therapy), number of parental visits, PMA, days of life, behavioural state during feeding measured on a 3‐point scale and episodes of apnoea, bradycardia and/or oxygen desaturation at the 3 monitored oral feeding sessions.
Notes	Adverse events were not reported although they were recorded as part of the protocol. Although not stated in the study, the profile of these study participants is the same as in Fucile 2011.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Although it was not explicitly stated, this paper appears to report secondary outcomes for infants described in Fucile 2011, as identical numbers of infants are reported in each of the 4 groups. If so, infants in Fucile 2011 were randomised in blocks (size not stated) stratified by gestational age (26 to 29 and 30 to 32 weeks GA) and time (3‐month intervals).
Allocation concealment (selection bias)	Unclear risk	This was not described, although a screen was placed around the incubator for all interventions.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Caregivers were blinded. All interventions were administered by the same researcher, who therefore must have been aware of allocation.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Unblinded researcher assessed outcomes.
Incomplete outcome data (attrition bias) All outcomes	High risk	Some outcomes were reported for all 75 infants; some data were missing.
Selective reporting (reporting bias)	High risk	All of the study’s prespecified outcomes and all expected outcomes of interest to the review have not been reported. The protocol specifies that the following co‐variates were considered and recorded: severity of illness, number of infants receiving all or partial breast feeding, number of co‐interventions (occupational/physical and/or speech therapy), number of parental visits, PMA, days of life, behavioural state during feeding measured on a 3‐point scale and episodes of apnoea, bradycardia and/or oxygen desaturation at the 3 monitored oral feeding sessions. No outcomes were reported for these co‐variates.
Other bias	High risk	Although it was not stated in the study, the profile of these study participants is the same as in Fucile 2011.