Shaw 1999.
Methods | Single‐centre RCT. 12 month follow‐up. Conducted in UK. | |
Participants | 101 otherwise healthy babies with clefts of lip, palate, lip and palate. Age: randomised at birth. Gender (m/f): Gp1 = 27/22, Gp2 = 31/21. Isolated cleft lip: Gp1 = 10, Gp2 = 15. Isolated cleft palate: Gp1 = 16, Gp2 = 15. Cleft lip and palate: Gp1 = 23, Gp2 = 22. South Asian mother: Gp1 = 4, Gp2 = 12. | |
Interventions | Gp1. Squeezable bottle with Nuk orthodontic teat (n = 49). Gp2. Rigid bottle with Nuk orthodontic teat (n = 52). All mother‐infant pairs received individual assessment of infant's oral feeding. | |
Outcomes | Weight (kg), head circumference (cm) and crown‐heel length (cm) were measured by trained researcher at birth, 6, 13, 26 and 52 weeks. Parental satisfaction was recorded as mothers report of ease/pleasure of feeding. 24 hour log of time taken to feed. Reliability of feeding methods (number of adjustments necessary). | |
Notes | Funded by Action Research Grant and North West Regional Health Authority, UK. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Generated by trial statistician. |
Allocation concealment? | Low risk | Opaque envelopes opened by clinician. |
Blinding? All outcomes | High risk | Outcome assessor was trial investigator. |
Incomplete outcome data addressed? All outcomes | Low risk | Drop outs listed and described in full. |
Free of selective reporting? | Low risk | Length, height and head circumference measures listed. |
Free of other bias? | Low risk | Comparable baseline data. Adequate follow‐up period. |
FTT ‐ Failure to thrive, defined as weight less than fifth centile NCHS ‐ National Centre for Health Statistics