Dataset Information

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.).

SUBMITTER: Gamble C

PROVIDER: S-EPMC10880183 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Timing of Primary Surgery for Cleft Palate.

Gamble Carrol C Persson Christina C Willadsen Elisabeth E Albery Liz L Soegaard Andersen Helene H Zattoni Antoneli Melissa M Appelqvist Malin M Aukner Ragnhild R Bodling Pia P Bowden Melanie M Brunnegård Karin K Cairns Gillian G Calladine Samantha S Campbell Linsay L Clayton-Smith Jill J Cooper Rachael R Conroy Elizabeth E El-Angbawi Ahmed A Kildegaard Emborg Berit B Enfält Wikman Josefin J Fitzpatrick Beth B Fukushiro Ana Paula AP Guedes de Azevedo Bento Gonçalves Cristina C Havstam Christina C Hvistendahl Anne Katherine AK Jorgensen Line Dahl LD Klinto Kristina K Berntsen Kvinnsland Marit M Larham Catriona C Lemvik Jorunn J Leturgie Louise L Liljerehn Eva E Lodge Natalie N Lohmander Anette A McMahon Siobhan S Mehendale Felicity F Miguel Haline Coracine HC Moe Marianne M Nielsen Joan Bogh JB Nyberg Jill J Pedersen Nina-Helen NH Phippen Ginette G Alvarez Piazentin-Penna Silvia Helena SH Patrick Kathryn K Pliskin Lindsay L Rigby Lucy L Semb Gunvor G Southby Lucy L Sporre Maria M Björkman Taleman Ann-Sofie AS Tangstad Jorid J Trindade Inge Elly Kiemle IEK Underwood Imogen I van Eeden Stephanie S Westberg Liisi Raud LR Williamson Paula Ruth PR Paciello Yamashita Renata R Munro Kevin K Walsh Tanya T Shaw William W

The New England journal of medicine 20230801 9

<h4>Background</h4>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.<h4>Methods</h4>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. Sta ...[more]

PMID: 37646677

Similar Datasets

Project description:BackgroundCleft of the lip and palate is the most common craniofacial birth defect with a worldwide incidence of one in 700 live births. Early surgical repairs are aimed at improving appearance, speech, hearing, psychosocial development and avoiding impediments to social integration. Many interventions including the Smile Train partner model have been introduced to identify and perform prompt surgical procedures for the affected babies. However, little is known about the trends of the incidence and surgical procedures performed at our hospital. Nothing is also known about the relationship between the clinical characteristics of the patients and the timing of primary repairs.ObjectiveTo determine the trends in cleft surgeries, patterns of cleft surgeries and identify factors related to late primary repair at the University College Hospital, UCH, Ibadan, Nigeria.MethodsA retrospective cohort study and trends analysis of babies managed for cleft lip and palate from January 2007 to January 2019 at the UCH, Ibadan was conducted. The demographic and clinical characteristics were extracted from the Smile Train enabled cleft database of the hospital. The annual trends in rate of cleft surgeries (number of cleft surgeries per 100,000 live births) was represented graphically. Chi square test, Student's t-test and Mann Whitney U were utilised to assess the association between categorical and continuous variables and delay in cleft surgery (≥12 months for lip repair, ≥18months for palatal repair). Kaplan-Meier graphs with log-rank test was used to examine the association between sociodemographic variables and the outcome (late surgery). Univariable and multivariable Cox proportional hazard regression was conducted to obtain the hazard or predictors of delayed cleft lip surgery. Stata version 17 (Statacorp, USA) statistical software was utilised for analysis.ResultsThere were 314 cleft surgeries performed over the thirteen-year period of study. The male to female ratio was 1.2:1. The mean age of the patients was 58.08 ± 99.65 months. The median age and weight of the patients were 11 (IQR:5-65) months and 8 (IQR: 5.5-16) kg respectively. Over half (n = 184, 58.6%) of the cleft surgeries were for primary repairs of the lip and a third (n = 94, 29.9%) were surgeries for primary repairs of the palate. Millard's rotation advancement flap was the commonest lip repair technique with Fishers repair introduced within two years into the end of the study. Bardachs two flap palatoplasty has replaced Von Langenbeck palatoplasty as the commonest method of palatal repair. The prevalence of late primary cleft lip repair was about a third of the patients having primary cleft lip surgery while the prevalence of late palatal repair was more than two thirds of those who received primary palatoplasty. Compared with children who had bilateral cleft lip, children with unilateral cleft lip had a significantly increased risk of late primary repair (Adj HR: 22.4, 955 CI: 2.59-193.70, P-value = 0.005).ConclusionThere has been a change from Von Langenbeck palatoplasty to Bardachs two-flap palatoplasty. Intra-velar veloplasty and Fisher's method of lip repair were introduced in later years. There was a higher risk of late primary repair in children with unilateral cleft lip.

Dataset Information

Timing of Primary Surgery for Cleft Palate.

Background

Methods

Results

Conclusions

Publications

Timing of Primary Surgery for Cleft Palate.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets