Masarei 2007.

Methods	Single‐centre RCT conducted across North Thames Regional Cleft Centre's two sites. 6 month intervention, 12 month follow‐up. Conducted in UK.
Participants	50 babies, 34 with unilateral cleft lip and palate (UCLP) and 16 with isolated cleft palate (ICP). Those requiring cardiac surgery or with neurological impairment and/or syndrome known to adversely affect feeding were excluded. One baby withdrawn from study due to medical complications. Gestational age: Gp1, UCLP = 39.75 weeks, ICP = 39.21 weeks. Gp2, UCLP = 39.61 weeks, ICP = 40.29 weeks. Gender (m/f): GP1 = 16 male, 9 female, Gp2 = 14 male, 10 female. UCLP: Gp1 = 17, Gp2 = 16. ICP: Gp1 = 8, Gp2 = 8.
Interventions	Gp1. Presurgical Orthopedics (PSO) or maxillary plate (presurgical) (n = 25). Gp2. No PSO (presurgical) (n = 24). All Cleft palates were repaired when child was 6 months old.
Outcomes	Weight (kg) recorded at birth, 3‐months and 12‐months of age. Height (cm) recorded at 3‐months and 12‐months of age. Head circumference (cm) recorded at 3‐months and 12‐months of age.
Notes	Funded Action Research.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Computer sequence generation using MINIM.
Allocation concealment?	Low risk	Allocation handled using automated computer generation.
Blinding? All outcomes	High risk	Speech and language therapists were blinded for sucking reflexes. Height and weight measures taken by study researcher.
Incomplete outcome data addressed? All outcomes	Unclear risk	3‐month data ‐ adequate. 12‐month data contains drop outs not reported.
Free of selective reporting?	Unclear risk	6‐month pre‐surgery data not presented.
Free of other bias?	Unclear risk	The maxillary plate group received more visits and checks during study than control group. Compliance with using the plate is unclear.