Timing of Primary Surgery for Cleft Palate

被引：34

作者：

Gamble, Carrol ^{[1
]}

Persson, Christina ^{[16
]}

Willadsen, Elisabeth ^{[25
]}

Albery, Liz ^{[8
]}

Andersen, Helene Soegaard ^{[26
]}

Antoneli, Melissa Zattoni ^{[28
]}

Appelqvist, Malin ^{[18
]}

Aukner, Ragnhild ^{[29
]}

Bodling, Pia ^{[19
]}

Bowden, Melanie ^{[10
]}

Brunnegard, Karin ^{[20
]}

Cairns, Gillian ^{[3
]}

Calladine, Samantha ^{[5
]}

Campbell, Linsay ^{[7
]}

Clayton-Smith, Jill ^{[9
]}

Cooper, Rachael ^{[1
]}

Conroy, Elizabeth ^{[1
]}

El-Angbawi, Ahmed ^{[9
]}

Emborg, Berit Kildegaard ^{[27
]}

Wikman, Josefin Enfalt ^{[21
]}

Fitzpatrick, Beth ^{[11
]}

Fukushiro, Ana Paula ^{[28
]}

de Azevedo Bento Goncalves, Cristina Guedes ^{[28
]}

Havstam, Christina ^{[17
]}

Hvistendahl, Anne Katherine ^{[29
]}

Jorgensen, Line Dahl ^{[25
,26
]}

Klinto, Kristina ^{[22
]}

Kvinnsland, Marit Berntsen ^{[29
]}

Larham, Catriona ^{[6
]}

Lemvik, Jorunn ^{[29
]}

Leturgie, Louise ^{[27
]}

Liljerehn, Eva ^{[18
]}

Lodge, Natalie ^{[3
]}

Lohmander, Anette ^{[23
]}

McMahon, Siobhan ^{[2
]}

Mehendale, Felicity ^{[4
]}

Miguel, Haline Coracine ^{[28
]}

Moe, Marianne ^{[30
]}

Nielsen, Joan Bogh ^{[27
]}

Nyberg, Jill ^{[23
]}

Pedersen, Nina-Helen ^{[31
]}

Phippen, Ginette ^{[13
]}

Alvarez Piazentin-Penna, Silvia Helena ^{[28
]}

Patrick, Kathryn ^{[10
]}

Pliskin, Lindsay ^{[1
]}

Rigby, Lucy ^{[14
]}

Semb, Gunvor ^{[9
]}

Southby, Lucy ^{[15
]}

Sporre, Maria ^{[22
]}

Taleman, Ann-Sofie Bjorkman ^{[19
]}

机构：

[1] Univ Liverpool, Liverpool, Merseyside, England

[2] Alder Hey Childrens NHS Fdn Trust, Liverpool, Merseyside, England

[3] Royal Hosp Sick Children, Edinburgh, Midlothian, Scotland

[4] Univ Edinburgh, Edinburgh, Midlothian, Scotland

[5] Northern & Yorkshire Reg Cleft Lip & Palate Serv, Leeds, W Yorkshire, England

[6] Leeds Gen Infirm, Leeds, W Yorkshire, England

[7] Cleft Care Scotland, Glasgow, Lanark, Scotland

[8] Bristol Dent Hosp, Bristol, Avon, England

[9] Univ Manchester, Manchester, Lancs, England

[10] Manchester Univ NHS Fdn Trust, Manchester, Lancs, England

[11] Birmingham Childrens Hosp, Birmingham, W Midlands, England

[12] Birmingham Womens & Childrens NHS Fdn Trust, Birmingham, W Midlands, England

[13] Salisbury Dist Hosp, Salisbury, Wilts, England

[14] Royal Victoria Infirm, Newcastle Upon Tyne, Tyne & Wear, England

[15] Oxford Univ Hosp NHS Fdn Trust, Oxford, England

[16] Univ Gothenburg, Gothenburg, Sweden

[17] Sahlgrens Univ Hosp, Gothenburg, Sweden

[18] Uppsala Univ Hosp, Uppsala, Sweden

[19] Linkoping Univ Hosp, Linkoping, Sweden

[20] Umea Univ, Umea, Sweden

[21] Norrlands Univ Hosp, Umea, Sweden

[22] Skane Univ Hosp, Malmo, Sweden

[23] Karolinska Inst, Solna, Sweden

[24] Karolinska Univ Hosp, Stockholm, Sweden

[25] Univ Copenhagen, Copenhagen, Denmark

[26] Copenhagen Cleft Palate Ctr, Copenhagen, Denmark

[27] Cleft Palate Ctr, Aarhus, Denmark

[28] Univ Sao Paulo, Bauru, SP, Brazil

[29] Statped, Oslo, Norway

[30] Statped Sorost, Oslo, Norway

[31] Statped Vest, Bergen, Norway

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2023年 / 389卷 / 09期

关键词：

SCANDCLEFT RANDOMIZED-TRIALS; SPEECH OUTCOMES; LIP; 5-YEAR-OLDS; PALATOPLASTY; VALIDITY; CHILDREN; REPAIR;

D O I：

10.1056/NEJMoa2215162

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.)

引用

页码：795 / 807

页数：13

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