Timing of Primary Surgery for Cleft Palate.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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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, Tangstad Jorid, Trindade Inge Elly Kiemle, Underwood Imogen, van Eeden Stephanie, Westberg Liisi Raud, Williamson Paula Ruth, Paciello Yamashita Renata, Munro Kevin, Walsh Tanya, Shaw William, TOPS Study Group
Аннотация
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.).