Brine 1994.

Methods	Single‐centre RCT. 18 month follow‐up. Conducted in USA.
Participants	37 babies with cleft palate or cleft lip and palate, prior to closure. Babies with malformation syndromes, recognised medical conditions or any infant associated anomalies were excluded. Age: 0 to 64 days (median 15). Gender (m/f): Gp1 = 13/5, Gp2 = 8/5. Cleft lip and palate: Gp1 = 13, Gp2 = 9. Isolated cleft palate: Gp1 = 5, Gp2 = 4.
Interventions	Gp1. Squeezable nurser (Mead Johnson Nutritionals) (n = 18). Gp2. Rigid bottle with standard cross‐cut nipple, cut 0.5 to 1 cm across each centre hole (n = 13). Both groups received feeding advice, nutritional counselling, feed equipment and feed formula. An intraoral maxillary obturator was fitted for infants with complete CL&P. Any mother whose infant had failure to thrive (FTT) received extra counselling and concentrated formula.
Outcomes	Anthropometric data included: weight (kg, using calibrated scales); length (cm), head circumference (cm), triceps and subscapular skinfold measurements (to nearest 0.1 mm approx 3 seconds after application of skinfold calipers); mid‐arm circumference (cm). Measurements taken at study entry, 3, 6, 9, 12 and 18 months of age. Weight for length and head circumference percentiles determined using NCHS data. Energy and protein intakes calculated from food records. All outcomes assessed by two trained paediatric dietitians.
Notes	Funded by James Whitcomb Riley Hospital for Children, Indianapolis, USA.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Sequence generation not reported.
Allocation concealment?	Unclear risk	Not reported.
Blinding? All outcomes	High risk	No blinding of outcome assessor. Researchers were responsible for data assessment.
Incomplete outcome data addressed? All outcomes	High risk	No drop outs listed. No reasons for attrition given.
Free of selective reporting?	Low risk	Length, weight and head circumference all reported.
Free of other bias?	Low risk	Acceptable follow‐up period of 18 months. Comparable baseline data for length, weight and head circumference.