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TOPS

Timing Of Primary Surgery for Cleft Palate

TOPS

Timing Of Primary Surgery for Cleft Palate
Funding National Institute of Dental and Craniofacial Research, National Institutes of Health (NIH)
Portfolio Paediatric, foetal and maternal health,Surgical
Interventions Other
Randomised True
Status Closed
Start Date 13-Jul-2010

TOPS is a trial to find the best age at which to repair a cleft palate.

558 infants with an isolated cleft palate have been recruited from cleft palate centres across 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.

Lay Summary of Results can be viewed here.

Publications

  • Carrol Gamble, Christina Persson, Elisabeth Willadsen, Liz Albery, Helene Soegaard Andersen, Melissa Zattoni Antoneli, Malin Appelqvist, Ragnhild Aukner, Pia Bodling, Melanie Bowden, Karin Brunnegård, Gillian Cairns et al Timing of Primary Surgery for Cleft Palate
    1. https://www.nejm.org/doi/full/10.1056/NEJMoa2215162
  • Shaw W, Semb G, Lohmander A, et alTiming Of Primary Surgery for cleft palate (TOPS): protocol for a randomised trial of palate Surgery at 6 months versus 12 months of ageBMJ Open 2019;9:e029780.
    1. https://doi.org/10.1136/bmjopen-2019-029780
  • Elisabeth Willadsen, Christina Persson & Duncan Appelbe (2018) A software program to assist coding of prelinguistic vocalizations in real time, Clinical Linguistics & Phonetics, 32:10, 972-978.
    1. https://doi.org/10.1080/02699206.2018.1463396
  • Conroy, E.J., Cooper, R., Shaw, W. Persson C, Willadsen E, Munro KJ, Williamson PR, Semb G, Walsh T, Gamble C & On behalf of the TOPS trial management group. A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan. Trials 22, 5 (2021).
    1. https://doi.org/10.1186/s13063-020-04886-y
  • Willadsen, E., Cooper, R., Conroy, E., Gamble, C., Albery, L., Andersen, H., Appelqvist, M., Bodling, P., Bowden, M., Brunnegard, K. and Enfalt, J., 2022. Inter-rater reliability in classification of canonical babbling status based on canonical babbling ratio in infants with isolated cleft palate randomised to Timing of Primary Surgery for Cleft Palate (TOPS). Clinical Linguistics & Phonetics, pp.1-22.
    1. https://doi.org/10.1080/02699206.2021.2012259
  • Christina Persson , Elizabeth J. Conroy , Carrol Gamble , Anna Rosala Hallas , William Shaw & Elisabeth Willadsen (2021) Adding a fourth rater to three had little impact in pre-linguistic outcome classification, Clinical Linguistics & Phonetics, 35:2, 138-153
    1. https://doi.org/10.1080/02699206.2020.1758793
  • Elisabeth Willadsen, Christina Persson, Kathryn Patrick, Anette Lohmander & D. Kimbrough Oller (2020) Assessment of prelinguistic vocalizations in real time: a comparison with phonetic transcription and assessment of inter-coder-reliability, Clinical Linguistics & Phonetics, 34:7, 593-616
    1. https://doi.org/10.1080/02699206.2019.1681516