Pimenta 2008.

Methods	Country: Brazil RCT
Participants	2 groups of healthy, stable, low birth weight, preterm infants were enrolled. 98 were enrolled; 96 remained in the study until they reached corrected age of 6 months. Group 1 (Experimental): N = 47, GA at birth 30.5 ± 1.2 weeks, GA (range) on reaching clinical stability 32 (28.6 to 35.5) weeks GA, birth weight 1204 ± 222 grams Group 2 (Control): N = 49, GA at birth 30.2 ± 1.8 weeks, GA (range) on reaching clinical stability 32.4 (27.5 to 34.4) weeks, birth weight 1125 ± 221 grams
Interventions	Experimental group received a standardised sensory‐motor‐oral stimulation programme and non‐nutritive sucking, delivered by 3 trained SLTs. Groups were followed until 6 months corrected age. Group 1 (Experimental): finger stimulation programme and NNS with a pacifier, as per Fucile 2002, performed once a day for 15 minutes during gavage feed for 10 days until oral diet commenced Group 2 (Control): sham stimulation during which the researcher stood around the incubator for the same length of time as group 1, while infants were positioned and gavage fed. No stimulation or pacifier was offered.
Outcomes	Breast feeding rates on discharge (%) Breast feeding rates at 3 months Breast feeding rates at 6 months Length of stay
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Infants were randomly assigned"; sequence generation was not described.
Allocation concealment (selection bias)	Low risk	Sequentially numbered, sealed, opaque, non‐translucent envelopes were used.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blinding of medical staff at the neonatal intensive care unit and at the outpatient ward, of nursing staff who provided care to the infants, of the speech therapist who assessed infant capacity to begin sucking and of mothers was reported. Three speech therapists who delivered intervention or sham procedure to enrolled infants were not blinded to group allocation. Therefore, some key study personnel were not blinded, but as outcome assessors and all other personnel were blinded, non‐blinding of researchers is unlikely to introduce bias.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	A single external SLT who was double‐blinded performed clinical assessment of ability to initiate oral feeding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Two infants in experimental group were lost to follow‐up at 6 months. Intention‐to‐treat analysis was reported. Reasons for loss to follow‐up were not given.
Selective reporting (reporting bias)	Unclear risk	All of the study’s prespecified outcomes and all expected outcomes of interest to the review have been reported.
Other bias	Unclear risk	It is unclear whether other biases were present.