title: Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 4. Speech outcomes in 5-year-olds - velopharyngeal competency and hypernasality.
abstract: OBJECTIVE
  Adequate velopharyngeal function and speech are main goals in the treatment of cleft palate. The objective was to investigate if there were differences in velopharyngeal competency (VPC) and hypernasality at age 5 years in children with unilateral cleft lip and palate (UCLP) operated on with different surgical methods for primary palatal repair. A secondary aim was to estimate burden of care in terms of received additional secondary surgeries and speech therapy.
  
  
  METHODS
  Three parallel group, randomised clinical trials were undertaken as an international multicentre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK.
  
  
  METHODS
  Three different surgical protocols for primary palatal repair were tested against a common procedure in the total cohort of 448 children born with a non-syndromic UCLP. Speech audio and video recordings of 391 children (136 girls, 255 boys) were available and perceptually analysed. The main outcome measures were VPC and hypernasality from blinded assessments.
  
  
  RESULTS
  There were no statistically significant differences between the prevalences in the arms in any of the trials. VPC: Trial 1, A: 58%, B: 61%; Trial 2, A: 57%, C: 54%; Trial 3, A: 35%, D: 51%. No hypernasality: Trial 1, A: 54%, B: 44%; Trial 2, A: 47%, C: 51%; Trial 3, A: 34%, D: 49%.
  
  
  CONCLUSIONS
  No differences were found regarding VPC and hypernasality at age 5 years after different methods for primary palatal repair. The burden of care in terms of secondary pharyngeal surgeries, number of fistulae, and speech therapy visits differed.
  
  
  BACKGROUND
  ISRCTN29932826.
authors.affiliation: a Division of Speech and Language Pathology , Karolinska Institutet, and Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Anette
authors.initials: A
authors.lastname: Lohmander
authors.affiliation: b Institute of Neuroscience and Physiology, Speech and Language Pathology Unit, Division of Speech and Language Pathology , Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital , Gothenburg , Sweden.
authors.forename: Christina
authors.initials: C
authors.lastname: Persson
authors.affiliation: c Department of Nordic Studies and Linguistics , University of Copenhagen , Denmark.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Willadsen
authors.affiliation: d Division of Speech and Language Pathology , Linköping University , Linköping , Sweden.
authors.forename: Inger
authors.initials: I
authors.lastname: Lundeborg
authors.affiliation: e Cleft Palate and Craniofacial Center , Helsinki University Central Hospital , Finland.
authors.forename: Suvi
authors.initials: S
authors.lastname: Alaluusua
authors.affiliation: f Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.
authors.forename: Ragnhild
authors.initials: R
authors.lastname: Aukner
authors.affiliation: g Copenhagen Cleft Palate Center , University Hospital of Copenhagen , Denmark.
authors.forename: Anja
authors.initials: A
authors.lastname: Bau
authors.affiliation: g Copenhagen Cleft Palate Center , University Hospital of Copenhagen , Denmark.
authors.forename: Maria
authors.initials: M
authors.lastname: Boers
authors.affiliation: h Department of Plastic Surgery, Greater Manchester Cleft Unit , Royal Manchester Children's Hospital , Manchester , UK.
authors.forename: Melanie
authors.initials: M
authors.lastname: Bowden
authors.affiliation: h Department of Plastic Surgery, Greater Manchester Cleft Unit , Royal Manchester Children's Hospital , Manchester , UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Davies
authors.affiliation: i Cleft Palate Center , Aarhus , Denmark.
authors.forename: Berit
authors.initials: B
authors.lastname: Emborg
authors.affiliation: j Division of Speech and Language Pathology , Sahlgrenska University Hospital , Gothenburg , Sweden.
authors.forename: Christina
authors.initials: C
authors.lastname: Havstam
authors.affiliation: k The Royal Hospital for Sick Children , Belfast , Northern Ireland.
authors.forename: Christine
authors.initials: C
authors.lastname: Hayden
authors.affiliation: l Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Gunilla
authors.initials: G
authors.lastname: Henningsson
authors.affiliation: m Statped Vest , Bergen , Norway.
authors.forename: Anders
authors.initials: A
authors.lastname: Holmefjord
authors.affiliation: e Cleft Palate and Craniofacial Center , Helsinki University Central Hospital , Finland.
authors.forename: Elina
authors.initials: E
authors.lastname: Hölttä
authors.affiliation: i Cleft Palate Center , Aarhus , Denmark.
authors.forename: Mia
authors.initials: M
authors.lastname: Kisling-Møller
authors.affiliation: f Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.
authors.forename: Lillian
authors.initials: L
authors.lastname: Kjøll
authors.affiliation: l Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Maria
authors.initials: M
authors.lastname: Lundberg
authors.affiliation: k The Royal Hospital for Sick Children , Belfast , Northern Ireland.
authors.forename: Eilish
authors.initials: E
authors.lastname: McAleer
authors.affiliation: l Stockholm Craniofacial Team , Karolinska University Hospital , Stockholm , Sweden.
authors.forename: Jill
authors.initials: J
authors.lastname: Nyberg
authors.affiliation: e Cleft Palate and Craniofacial Center , Helsinki University Central Hospital , Finland.
authors.forename: Marjukka
authors.initials: M
authors.lastname: Paaso
authors.affiliation: m Statped Vest , Bergen , Norway.
authors.forename: Nina Helen
authors.initials: NH
authors.lastname: Pedersen
authors.affiliation: m Statped Vest , Bergen , Norway.
authors.forename: Therese
authors.initials: T
authors.lastname: Rasmussen
authors.affiliation: m Statped Vest , Bergen , Norway.
authors.forename: Sigvor
authors.initials: S
authors.lastname: Reisæter
authors.affiliation: g Copenhagen Cleft Palate Center , University Hospital of Copenhagen , Denmark.
authors.forename: Helene
authors.initials: H
authors.lastname: Søgaard Andersen
authors.affiliation: g Copenhagen Cleft Palate Center , University Hospital of Copenhagen , Denmark.
authors.forename: Antje
authors.initials: A
authors.lastname: Schöps
authors.affiliation: f Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.
authors.forename: Inger-Beate
authors.initials: IB
authors.lastname: Tørdal
authors.affiliation: f Department of Speech and Language Disorders , Statped sørøst , Oslo , Norway.|n School of Dentistry , University of Manchester , Manchester , UK.|o Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.
authors.forename: Gunvor
authors.initials: G
authors.lastname: Semb
mesh_terms: D002675:Child, Preschool; D002971:Cleft Lip / Q000175:diagnosis / Q000601:surgery*; D002972:Cleft Palate / Q000175:diagnosis / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D038622:Internationality; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology / Q000503:physiopathology; D016032:Randomized Controlled Trials as Topic; D019651:Plastic Surgery Procedures / Q000009:adverse effects / Q000379:methods*; D020127:Recovery of Function; D018570:Risk Assessment; D013064:Speech Disorders / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D013070:Speech Therapy / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome; D014681:Velopharyngeal Insufficiency / Q000209:etiology / Q000517:prevention & control*
keywords: Randomised clinical trial; Scandcleft; cross-linguistic; intercentre study; primary palatal repair; speech; unilateral cleft lip and palate