Manchester dental researchers awarded more than £5 million to look into if timing of infant’s cleft palate surgery has an influence on speech development
Researchers at Central Manchester University
Hospitals NHS Foundation Trust (CMFT) and The University of
Manchester have been awarded more than £5 million to evaluate
the timing of surgery for infants with cleft palate.
The National Institute
of Dental and Craniofacial Research (NIDCR), a branch of the
U.S.National Institutes of
Health, has contributed the follow-up grant ($7.6 million) for
the TOPS (Timing of Primary Surgery for Cleft Palate) clinical
The money will allow the team of researchers, led by Honorary
Professor William Shaw and Honorary Senior Lecturer, Dr Gunvor
Semb, to complete the TOPS trial over the next five years.
The international TOPS study is looking into the timing of
surgery for cleft palate in infants and compares the results of
surgery performed at either 6 or 12 months. It involves data over a
wide range of disciplines such as clinical genetics, speech and
language pathology, audiology and orthodontics.
A review of surgical practice across the UK and Scandinavia
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.
More than 550 infants with cleft palate were recruited at 23
sites in the UK, Denmark, Norway, Sweden and Brazil between
September 2010 and July 2015, with a grant that the NIDCR
previously awarded. Babies who participated in the trial received
surgery using the same technique (Sommerlad technique) and were
randomly assigned to have their surgery when they are either aged 6
months or 12 months. There was a 50:50 chance of infants being in
After surgery, children taking part will be followed up at age
12 months, three years and five years when speech, hearing and
physical development will be reviewed.
Professor Shaw said: "The main objective of this trial is to
determine whether the timing of the cleft palate surgery has an
influence on speech development. We hope that through this study we
will be able to offer recommendations to help shape surgical
procedures for young patients with cleft palate in the future.
"We also aim to help improve early speech and hearing, and thus
the social integration of affected children; to reduce the burden
of remedial care and secondary surgery that they and their families
presently endure and to reduce the financial costs of care
associated with cleft palate."
The TOPS site at CMFT was the first to start recruitment for the
study in September 2010, and Manchester is hosting the data
evaluation meetings planned until 2020.
For more information, visit the TOPS trial
website or contact the TOPS Project Manager, Dr Dieter