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Timing of Primary Surgery for Cleft Palate

Gamble, Carrol ; Persson, Christina LU ; Willadsen, Elisabeth ; Albery, Liz ; Soegaard Andersen, Helene ; Zattoni Antoneli, Melissa ; Appelqvist, Malin ; Aukner, Ragnhild ; Bodling, Pia and Bowden, Melanie , et al. (2023) In The New England journal of medicine 389(9). p.795-807
Abstract

BACKGROUND: Among infants with isolated cleft palate, whether primary surgery at 6 months of age is more beneficial than surgery at 12 months of age with respect to speech outcomes, hearing outcomes, dentofacial development, and safety is unknown. METHODS: We randomly assigned infants with nonsyndromic isolated cleft palate, in a 1:1 ratio, to undergo standardized primary surgery at 6 months of age (6-month group) or at 12 months of age (12-month group) for closure of the cleft. Standardized assessments of quality-checked video and audio recordings at 1, 3, and 5 years of age were performed independently by speech and language therapists who were unaware of the trial-group assignments. The primary outcome was velopharyngeal... (More)

BACKGROUND: Among infants with isolated cleft palate, whether primary surgery at 6 months of age is more beneficial than surgery at 12 months of age with respect to speech outcomes, hearing outcomes, dentofacial development, and safety is unknown. METHODS: We randomly assigned infants with nonsyndromic isolated cleft palate, in a 1:1 ratio, to undergo standardized primary surgery at 6 months of age (6-month group) or at 12 months of age (12-month group) for closure of the cleft. Standardized assessments of quality-checked video and audio recordings at 1, 3, and 5 years of age were performed independently by speech and language therapists who were unaware of the trial-group assignments. The primary outcome was velopharyngeal insufficiency at 5 years of age, defined as a velopharyngeal composite summary score of at least 4 (scores range from 0 to 6, with higher scores indicating greater severity). Secondary outcomes included speech development, postoperative complications, hearing sensitivity, dentofacial development, and growth. RESULTS: We randomly assigned 558 infants at 23 centers across Europe and South America to undergo surgery at 6 months of age (281 infants) or at 12 months of age (277 infants). Speech recordings from 235 infants (83.6%) in the 6-month group and 226 (81.6%) in the 12-month group were analyzable. Insufficient velopharyngeal function at 5 years of age was observed in 21 of 235 infants (8.9%) in the 6-month group as compared with 34 of 226 (15.0%) in the 12-month group (risk ratio, 0.59; 95% confidence interval, 0.36 to 0.99; P = 0.04). Postoperative complications were infrequent and similar in the 6-month and 12-month groups. Four serious adverse events were reported (three in the 6-month group and one in the 12-month group) and had resolved at follow-up. CONCLUSIONS: Medically fit infants who underwent primary surgery for isolated cleft palate in adequately resourced settings at 6 months of age were less likely to have velopharyngeal insufficiency at the age of 5 years than those who had surgery at 12 months of age. (Funded by the National Institute of Dental and Craniofacial Research; TOPS ClinicalTrials.gov number, NCT00993551.).

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Contribution to journal
publication status
published
subject
in
The New England journal of medicine
volume
389
issue
9
pages
795 - 807
publisher
Massachusetts Medical Society
external identifiers
  • pmid:37646677
  • scopus:85168929469
ISSN
0028-4793
DOI
10.1056/NEJMoa2215162
language
English
LU publication?
no
additional info
Publisher Copyright: Copyright © 2023 Massachusetts Medical Society.
id
0297b96e-1bd5-4a26-a1d9-6e14e363e21c
date added to LUP
2023-09-08 09:43:29
date last changed
2024-04-20 02:59:00
@article{0297b96e-1bd5-4a26-a1d9-6e14e363e21c,
  abstract     = {{<p>BACKGROUND: Among infants with isolated cleft palate, whether primary surgery at 6 months of age is more beneficial than surgery at 12 months of age with respect to speech outcomes, hearing outcomes, dentofacial development, and safety is unknown. METHODS: We randomly assigned infants with nonsyndromic isolated cleft palate, in a 1:1 ratio, to undergo standardized primary surgery at 6 months of age (6-month group) or at 12 months of age (12-month group) for closure of the cleft. Standardized assessments of quality-checked video and audio recordings at 1, 3, and 5 years of age were performed independently by speech and language therapists who were unaware of the trial-group assignments. The primary outcome was velopharyngeal insufficiency at 5 years of age, defined as a velopharyngeal composite summary score of at least 4 (scores range from 0 to 6, with higher scores indicating greater severity). Secondary outcomes included speech development, postoperative complications, hearing sensitivity, dentofacial development, and growth. RESULTS: We randomly assigned 558 infants at 23 centers across Europe and South America to undergo surgery at 6 months of age (281 infants) or at 12 months of age (277 infants). Speech recordings from 235 infants (83.6%) in the 6-month group and 226 (81.6%) in the 12-month group were analyzable. Insufficient velopharyngeal function at 5 years of age was observed in 21 of 235 infants (8.9%) in the 6-month group as compared with 34 of 226 (15.0%) in the 12-month group (risk ratio, 0.59; 95% confidence interval, 0.36 to 0.99; P = 0.04). Postoperative complications were infrequent and similar in the 6-month and 12-month groups. Four serious adverse events were reported (three in the 6-month group and one in the 12-month group) and had resolved at follow-up. CONCLUSIONS: Medically fit infants who underwent primary surgery for isolated cleft palate in adequately resourced settings at 6 months of age were less likely to have velopharyngeal insufficiency at the age of 5 years than those who had surgery at 12 months of age. (Funded by the National Institute of Dental and Craniofacial Research; TOPS ClinicalTrials.gov number, NCT00993551.).</p>}},
  author       = {{Gamble, Carrol and Persson, Christina and Willadsen, Elisabeth and Albery, Liz and Soegaard Andersen, Helene and Zattoni Antoneli, Melissa and Appelqvist, Malin and Aukner, Ragnhild and Bodling, Pia and Bowden, Melanie and Brunnegård, Karin and Cairns, Gillian and Calladine, Samantha and Campbell, Linsay and Clayton-Smith, Jill and Cooper, Rachael and Conroy, Elizabeth and El-Angbawi, Ahmed and Kildegaard Emborg, Berit and Enfält Wikman, Josefin and Fitzpatrick, Beth and Fukushiro, Ana Paula and Guedes de Azevedo Bento Gonçalves, Cristina and Havstam, Christina and Hvistendahl, Anne Katherine and Jorgensen, Line Dahl and Klinto, Kristina and Berntsen Kvinnsland, Marit and Larham, Catriona and Lemvik, Jorunn and Leturgie, Louise and Liljerehn, Eva and Lodge, Natalie and Lohmander, Anette and McMahon, Siobhan and Mehendale, Felicity and Miguel, Haline Coracine and Moe, Marianne and Nielsen, Joan Bogh and Nyberg, Jill and Pedersen, Nina Helen and Phippen, Ginette and Alvarez Piazentin-Penna, Silvia Helena and Patrick, Kathryn and Pliskin, Lindsay and Rigby, Lucy and Semb, Gunvor and Southby, Lucy and Sporre, Maria and Björkman Taleman, Ann Sofie}},
  issn         = {{0028-4793}},
  language     = {{eng}},
  month        = {{08}},
  number       = {{9}},
  pages        = {{795--807}},
  publisher    = {{Massachusetts Medical Society}},
  series       = {{The New England journal of medicine}},
  title        = {{Timing of Primary Surgery for Cleft Palate}},
  url          = {{http://dx.doi.org/10.1056/NEJMoa2215162}},
  doi          = {{10.1056/NEJMoa2215162}},
  volume       = {{389}},
  year         = {{2023}},
}