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Timing of Primary Surgery for Cleft Palate.
Gamble, Carrol; Persson, Christina; Willadsen, Elisabeth; Albery, Liz; Soegaard Andersen, Helene; Zattoni Antoneli, Melissa; Appelqvist, Malin; Aukner, Ragnhild; Bodling, Pia; Bowden, Melanie; Brunnegård, Karin; Cairns, Gillian; Calladine, Samantha; Campbell, Linsay; Clayton-Smith, Jill; Cooper, Rachael; Conroy, Elizabeth; El-Angbawi, Ahmed; Kildegaard Emborg, Berit; Enfält Wikman, Josefin; Fitzpatrick, Beth; Fukushiro, Ana Paula; Guedes de Azevedo Bento Gonçalves, Cristina; Havstam, Christina; Hvistendahl, Anne Katherine; Jorgensen, Line Dahl; Klinto, Kristina; Berntsen Kvinnsland, Marit; Larham, Catriona; Lemvik, Jorunn; Leturgie, Louise; Liljerehn, Eva; Lodge, Natalie; Lohmander, Anette; McMahon, Siobhan; Mehendale, Felicity; Miguel, Haline Coracine; Moe, Marianne; Nielsen, Joan Bogh; Nyberg, Jill; Pedersen, Nina-Helen; Phippen, Ginette; Alvarez Piazentin-Penna, Silvia Helena; Patrick, Kathryn; Pliskin, Lindsay; Rigby, Lucy; Semb, Gunvor; Southby, Lucy; Sporre, Maria; Björkman Taleman, Ann-Sofie.
Afiliação
  • Gamble C; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Persson C; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Willadsen E; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Albery L; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Soegaard Andersen H; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Zattoni Antoneli M; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Appelqvist M; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Aukner R; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Bodling P; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Bowden M; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Brunnegård K; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Cairns G; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Calladine S; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Campbell L; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Clayton-Smith J; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Cooper R; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Conroy E; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • El-Angbawi A; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Kildegaard Emborg B; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Enfält Wikman J; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Fitzpatrick B; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Fukushiro AP; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Guedes de Azevedo Bento Gonçalves C; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Havstam C; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Hvistendahl AK; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Jorgensen LD; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Klinto K; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Berntsen Kvinnsland M; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Larham C; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Lemvik J; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Leturgie L; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Liljerehn E; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Lodge N; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Lohmander A; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • McMahon S; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Mehendale F; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Miguel HC; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Moe M; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Nielsen JB; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Nyberg J; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Pedersen NH; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Phippen G; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Alvarez Piazentin-Penna SH; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Patrick K; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Pliskin L; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Rigby L; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Semb G; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Southby L; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Sporre M; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
  • Björkman Taleman AS; From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and
N Engl J Med ; 389(9): 795-807, 2023 Aug 31.
Article em En | MEDLINE | ID: mdl-37646677
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 11 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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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Insuficiência Velofaríngea / Fissura Palatina Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies Limite: Child, preschool / Humans / Infant País/Região como assunto: America do sul / Europa Idioma: En Revista: N Engl J Med Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Insuficiência Velofaríngea / Fissura Palatina Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies Limite: Child, preschool / Humans / Infant País/Região como assunto: America do sul / Europa Idioma: En Revista: N Engl J Med Ano de publicação: 2023 Tipo de documento: Article