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– There was previously limited evidence on the optimal age for cleft palate surgery in children to achieve the best results, he says Annette LohmanderProfessor Emeritus of Department of Clinical Sciences, Intervention and Technology At the Karolinska Institutet, which is responsible for the Swedish part of the study.
558 children from 23 different centers in Europe and South America participated in the study. 235 children were randomly assigned to a group to undergo surgery at six months of age. 226 children were randomly assigned to a group to undergo surgery at twelve months of age.
Speech therapists performed standardized audio and video recordings at 1, 3, and 5 years of age. The researchers then assessed the children’s palate and speech function.
At age five, researchers found insufficient palate function in 21 children (8.9%) who had surgery at six months, compared to 34 children (15%) who had surgery at 12 months.
Four serious adverse events were reported
Complications due to surgery were rare in both groups. Four serious adverse events were reported, but these resolved on follow-up.
The study concluded that children who had surgery at the age of six months had a lower risk of insufficient palate function for speech at the age of five compared to those who had surgery at the age of twelve months.
-An additional advantage of the early surgical age was the higher incidence of dirty clips. It is a milestone in children’s language development and is established in children with normal development by the age of ten months at the latest, says Annette Lohmander and continues:
The children included in the study did not have any developmental delays or other deviations. The conclusion is that when cleft palate surgery can be performed early, this seems to provide the best conditions for the development of speech and language.
This study was supervised by the University of Liverpool and the University of Manchester in England. The LKG team, the Speech Therapy Medical Unit at Karolinska University Hospital and corresponding units at other hospitals participated in the study. The study was mainly funded by the National Institute of Dental and Craniofacial Research, USA. The researchers reported that there were no conflicts of interest.
Publishing
“Timing of initial cleft palate surgeryC. Gamble, C. Persson, E. Willadsen, L. Albery, H. Soegaard Andersen, M. Zattoni Antoneli, M. Appelqvist, R. Aukner, P. Bodling, M. Bowden, K. Brunnegård, G. Cairns, S. Kaladin, L. Campbell, J. Clayton Smith, R. Cooper, E. Conroy, A. Al-Anjabafi, b. Kjeldegaard Emburg, c. Infalt Wickman, B. Fitzpatrick, A.P. Fukushiro, C. Guedes de Azevedo Pinto Gonçalves, C. Havstam, A. K. Havstendhal, L. D. Jorgensen, K. Klinto, M. Berntsen Kvinsland, C. Larham, J. Lemvik, L. liturgy, e. Lilgerin, N. Lodge, A. Lohmander, S. McMahon, F. Mehendale, H. C. Miguel, M. Moe, J. B. Nielsen, J. Nyberg, N.-H. Pedersen, J. Phippen, S.H. Álvarez and Biazentin-Pena, K. Patrick, L. Pliskin, L. Rigby, J. Semp, L. Southby, M. Spohr, A.-S. Bjorkman Tallman, J. Tangstad, Ek Trinidad, I. Underwood, S. Van Eeden, L.R. Westberg, P.R. Williamson, R. Basillo Yamashita, K. Monroe, T. Walsh, and W. Shaw, for the TOPS Study Group, New England Journal of Medicine, Online 31 August 2023, doi: 10.1056/NEJMoa2215162
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