Prahl 2005.

Methods	Multicentre RCT. 18 month follow‐up. Conducted in The Netherlands.
Participants	54 babies with complete unilateral cleft lip and palate. Babies born at term. Babies with other congenital malformations and soft tissue bands were excluded. Age: randomised within 2 weeks of birth. Gender: 41 boys, 13 girls.
Interventions	Gp1. Passive acrylic plate, worn 24 hour/day. Plates initially adjusted every 3 weeks. Plate maintained until surgical soft palate closure (n = 27). Gp2. No plate worn (n = 27). In both groups lip surgery was performed according to the Millard technique (18 weeks of age); soft palate closure was performed according to a modified Von Lagenbeck procedure (52 weeks of age).
Outcomes	Weight (kg) and length (cm) and feeding diaries. Weight‐for‐age, length‐for‐age and weight‐for‐length z‐scores were evaluated.
Notes	Funded by National Health Insurance Board of The Netherlands.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Computer balanced allocation procedure.
Allocation concealment?	Low risk	Computer balanced allocation procedure.
Blinding? All outcomes	Low risk	Weight and length measured by the National Infant Consultation Centers.
Incomplete outcome data addressed? All outcomes	Unclear risk	Reasons for drop outs not reported.
Free of selective reporting?	High risk	No reporting of head circumference.
Free of other bias?	Low risk	Comparable baseline data. Adequate follow‐up period.