Trial Summary

A review of surgical practice across the UK and Scandinavia has identified differences in the timing of primary surgery in infants with cleft palate. There is currently no reliable evidence to support that either primary surgery at age 6 months or age 12 months produces better outcomes, however, it is thought that the timing of surgery may influence speech development and for that reason the best possible timing should be assessed.

558 infants with an isolated cleft palate were recruited from cleft palate centres in the UK, Scandinavia and Brazil. Babies participating in the trial received surgery using the same technique (Sommerlad technique) and were randomly assigned to have their surgery when they were either aged 6 months or 12 months. There was a 50:50 chance of infants being in either group.

After surgery, children taking part in the TOPS trial are being followed up at age 12 months, 3 years and 5 years when speech, hearing and physical development are being reviewed.

The main objective of this trial is to determine whether the timing of the cleft palate surgery has an influence on speech development.

A schematic showing the trial design can be seen below: