Timing of Primary Surgery for Cleft Palate

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; Samantha Calladine; Linsay Campbell; Jill Clayton-Smith; Rachael Cooper; Elizabeth Conroy; Ahmed El-Angbawi; Berit Kildegaard Emborg; Josefin Enfält Wikman; Beth Fitzpatrick; Ana Paula Fukushiro; Cristina Guedes de Azevedo Bento Gonçalves; Christina Havstam; Anne Katherine Hvistendahl; Line Dahl Jorgensen; Kristina Klinto; Marit Berntsen Kvinnsland; Catriona Larham; Jorunn Lemvik; Louise Leturgie; Eva Liljerehn; Natalie Lodge; Anette Lohmander; Siobhan McMahon; Felicity Mehendale; Haline Coracine Miguel; Marianne Moe; Joan Bogh Nielsen; Jill Nyberg; Nina-Helen Pedersen; Ginette Phippen; Silvia Helena Alvarez Piazentin-Penna; Kathryn Patrick; Lindsay Pliskin; Lucy Rigby; Gunvor Semb; Lucy Southby; Maria Sporre; Ann-Sofie Björkman Taleman; TOPS Study Group

doi:10.1056/NEJMoa2215162

Timing of Primary Surgery for Cleft Palate

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, Samantha Calladine, Linsay Campbell, Jill Clayton-Smith, Rachael Cooper, Elizabeth Conroy, Ahmed El-Angbawi, Berit Kildegaard Emborg, Josefin Enfält WikmanBeth Fitzpatrick, Ana Paula Fukushiro, Cristina Guedes de Azevedo Bento Gonçalves, Christina Havstam, Anne Katherine Hvistendahl, Line Dahl Jorgensen, Kristina Klinto, Marit Berntsen Kvinnsland, Catriona Larham, Jorunn Lemvik, Louise Leturgie, Eva Liljerehn, Natalie Lodge, Anette Lohmander, Siobhan McMahon, Felicity Mehendale, Haline Coracine Miguel, Marianne Moe, Joan Bogh Nielsen, Jill Nyberg, Nina-Helen Pedersen, Ginette Phippen, Silvia Helena Alvarez Piazentin-Penna, Kathryn Patrick, Lindsay Pliskin, Lucy Rigby, Gunvor Semb, Lucy Southby, Maria Sporre, Ann-Sofie Björkman Taleman, TOPS Study Group

Læbe-Ganespalte Centret

34 Citationer (Scopus)

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 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.).

Originalsprog	Engelsk
Tidsskrift	The New England journal of medicine
Vol/bind	389
Udgave nummer	9
Sider (fra-til)	795-807
Antal sider	13
ISSN	0028-4793
DOI	https://doi.org/10.1056/NEJMoa2215162
Status	Udgivet - 31 aug. 2023

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10.1056/NEJMoa2215162

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Gamble, C., Persson, C., Willadsen, E., Albery, L., Soegaard Andersen, H., Zattoni Antoneli, M., Appelqvist, M., Aukner, R., Bodling, P., Bowden, M., Brunnegård, K., Cairns, G., Calladine, S., Campbell, L., Clayton-Smith, J., Cooper, R., Conroy, E., El-Angbawi, A., Kildegaard Emborg, B., ... TOPS Study Group (2023). Timing of Primary Surgery for Cleft Palate. The New England journal of medicine, 389(9), 795-807. https://doi.org/10.1056/NEJMoa2215162

Gamble, C, Persson, C, Willadsen, E, Albery, L, Soegaard Andersen, H, Zattoni Antoneli, M, Appelqvist, M, Aukner, R, Bodling, P, Bowden, M, Brunnegård, K, Cairns, G, Calladine, S, Campbell, L, Clayton-Smith, J, Cooper, R, Conroy, E, El-Angbawi, A, Kildegaard Emborg, B, Enfält Wikman, J, Fitzpatrick, B, Fukushiro, AP, Guedes de Azevedo Bento Gonçalves, C, Havstam, C, Hvistendahl, AK, Jorgensen, LD, Klinto, K, Berntsen Kvinnsland, M, Larham, C, Lemvik, J, Leturgie, L, Liljerehn, E, Lodge, N, Lohmander, A, McMahon, S, Mehendale, F, Miguel, HC, Moe, M, Nielsen, JB, Nyberg, J, Pedersen, N-H, Phippen, G, Alvarez Piazentin-Penna, SH, Patrick, K, Pliskin, L, Rigby, L, Semb, G, Southby, L, Sporre, M, Björkman Taleman, A-S & TOPS Study Group 2023, 'Timing of Primary Surgery for Cleft Palate', The New England journal of medicine, bind 389, nr. 9, s. 795-807. https://doi.org/10.1056/NEJMoa2215162

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title = "Timing of Primary Surgery for Cleft Palate",

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 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.).",

keywords = "Child, Preschool, Humans, Infant, Allied Health Personnel, Cleft Palate/complications, Europe, Postoperative Complications/epidemiology, Velopharyngeal Insufficiency/diagnosis, South America, Diagnostic Techniques, Surgical",

author = "Carrol Gamble and Christina Persson and Elisabeth Willadsen and Liz Albery and {Soegaard Andersen}, Helene and {Zattoni Antoneli}, Melissa and Malin Appelqvist and Ragnhild Aukner and Pia Bodling and Melanie Bowden and Karin Brunneg{\aa}rd and Gillian Cairns and Samantha Calladine and Linsay Campbell and Jill Clayton-Smith and Rachael Cooper and Elizabeth Conroy and Ahmed El-Angbawi and {Kildegaard Emborg}, Berit and {Enf{\"a}lt Wikman}, Josefin and Beth Fitzpatrick and Fukushiro, {Ana Paula} and {Guedes de Azevedo Bento Gon{\c c}alves}, Cristina and Christina Havstam and Hvistendahl, {Anne Katherine} and Jorgensen, {Line Dahl} and Kristina Klinto and {Berntsen Kvinnsland}, Marit and Catriona Larham and Jorunn Lemvik and Louise Leturgie and Eva Liljerehn and Natalie Lodge and Anette Lohmander and Siobhan McMahon and Felicity Mehendale and Miguel, {Haline Coracine} and Marianne Moe and Nielsen, {Joan Bogh} and Jill Nyberg and Nina-Helen Pedersen and Ginette Phippen and {Alvarez Piazentin-Penna}, {Silvia Helena} and Kathryn Patrick and Lindsay Pliskin and Lucy Rigby and Gunvor Semb and Lucy Southby and Maria Sporre and {Bj{\"o}rkman Taleman}, Ann-Sofie and {TOPS Study Group}",

note = "Copyright {\textcopyright} 2023 Massachusetts Medical Society.",

year = "2023",

month = aug,

day = "31",

doi = "10.1056/NEJMoa2215162",

language = "English",

volume = "389",

pages = "795--807",

journal = "The New England journal of medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "9",

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TY - JOUR

T1 - Timing of Primary Surgery for Cleft Palate

AU - Gamble, Carrol

AU - Persson, Christina

AU - Willadsen, Elisabeth

AU - Albery, Liz

AU - Soegaard Andersen, Helene

AU - Zattoni Antoneli, Melissa

AU - Appelqvist, Malin

AU - Aukner, Ragnhild

AU - Bodling, Pia

AU - Bowden, Melanie

AU - Brunnegård, Karin

AU - Cairns, Gillian

AU - Calladine, Samantha

AU - Campbell, Linsay

AU - Clayton-Smith, Jill

AU - Cooper, Rachael

AU - Conroy, Elizabeth

AU - El-Angbawi, Ahmed

AU - Kildegaard Emborg, Berit

AU - Enfält Wikman, Josefin

AU - Fitzpatrick, Beth

AU - Fukushiro, Ana Paula

AU - Guedes de Azevedo Bento Gonçalves, Cristina

AU - Havstam, Christina

AU - Hvistendahl, Anne Katherine

AU - Jorgensen, Line Dahl

AU - Klinto, Kristina

AU - Berntsen Kvinnsland, Marit

AU - Larham, Catriona

AU - Lemvik, Jorunn

AU - Leturgie, Louise

AU - Liljerehn, Eva

AU - Lodge, Natalie

AU - Lohmander, Anette

AU - McMahon, Siobhan

AU - Mehendale, Felicity

AU - Miguel, Haline Coracine

AU - Moe, Marianne

AU - Nielsen, Joan Bogh

AU - Nyberg, Jill

AU - Pedersen, Nina-Helen

AU - Phippen, Ginette

AU - Alvarez Piazentin-Penna, Silvia Helena

AU - Patrick, Kathryn

AU - Pliskin, Lindsay

AU - Rigby, Lucy

AU - Semb, Gunvor

AU - Southby, Lucy

AU - Sporre, Maria

AU - Björkman Taleman, Ann-Sofie

AU - TOPS Study Group

PY - 2023/8/31

Y1 - 2023/8/31

N2 - 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.).

AB - 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.).

KW - Child, Preschool

KW - Humans

KW - Infant

KW - Allied Health Personnel

KW - Cleft Palate/complications

KW - Europe

KW - Postoperative Complications/epidemiology

KW - Velopharyngeal Insufficiency/diagnosis

KW - South America

KW - Diagnostic Techniques, Surgical

UR - http://www.scopus.com/inward/record.url?scp=85168929469&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa2215162

DO - 10.1056/NEJMoa2215162

M3 - Journal article

C2 - 37646677

SN - 0028-4793

VL - 389

SP - 795

EP - 807

JO - The New England journal of medicine

JF - The New England journal of medicine

IS - 9

ER -

Timing of Primary Surgery for Cleft Palate

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