Patients/Families

The TOPS trial: Basics

The main aim of the TOPS trial is to find out whether the age at which babies have surgery to have their cleft palate repaired has an influence on the way their speech develops.  If surgery at one age produces better speech and fewer side-effects than surgery at another age, this may change the recommended time of surgery for all babies born with cleft palate.

Parents of babies born with isolated cleft palate (i.e. not affecting the lip), who attended one of the hospitals taking part in TOPS, were invited to take part in the trial. Taking part was voluntary and parents could have chosen for their child to have surgery at the usual time offered by the Hospital.

 

What happens if  my child is taking part in the trial?

If parents decided to take part in TOPS, the time that their baby had surgery was determined by a computer programme to make sure that both groups were equal. There are two groups: surgery at age 6 months and surgery at age 12 months.

Although the timing of surgery was different, the way that the surgery was done is the same for both groups. The Sommerlad technique was chosen as the method of surgery, because it is a well-established procedure intended to achieve optimal repair of the roof of the mouth which is most affected by the cleft for normal speech formation , and also because the majority of participating surgeons are already familiar with it.

All children are followed up for a period of up to 5 years and 11 months during which they will visit the hospital at the age of one year, 3 years and 5 years. During the visits, photographs of the mouth and or the face, video and audio recordings will be taken and their hearing will be assessed by a member of the research team. Data from these assessments will be examined by health professionals including speech and language therapists involved in the TOPS trial to find out how their speech is developing and to check their hearing, growth and other aspects of their development.

Some of the audio /video recordings taken of your child may also be used as part of the training of your speech therapist. They will be used to develop a training package for all of the speech and language therapists involved in the TOPS trial. We are doing this so that all of the speech therapists in the TOPS trial follow the same method when making their assessments.