NCT00993551

Brief Summary

This trial is a randomised controlled trial with a parallel design taking place in centres across the UK, Scandinavia and Brazil. 650 infants with a diagnosis of isolated cleft palate who are considered medically fit for operation at 6 months, and who meet the inclusion criteria, will be included in the trial and randomised to receive either:

  • Surgery at age 6 months, OR
  • Surgery at age 12 months. The main objective is to determine whether surgery for cleft palate, using a Sommerlad technique, at age 6 months, when compared to surgery using the same technique at age 12 months, improves velopharyngeal function at age 5 years. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes( at age 5 years) and secondary outcomes.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
558

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
5 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2021

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

10.1 years

First QC Date

October 9, 2009

Last Update Submit

August 6, 2021

Conditions

Cleft Palate

Keywords

cleft palatepaediatricpediatricsurgeryspeechvelopharyngeal

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure for the TOPS trial is insufficient velopharyngeal function.

    Unit of measure: Sufficient (VPC sum \<=3) or insufficient (VPC sum\>=4). VPC sum measured on scale from 1 to 6.

    5 years

Secondary Outcomes (16)

  • Velopharyngeal function;1.Velopharyngeal composite score summary (VPC sum) 2.Insufficient velopharyngeal function (VPC rate)

    3 and 5 years

  • Velopharyngeal function: Velopharyngeal insufficiency symptoms

    3 years

  • Canonical babbling; 1.Canonical babbling present 2.Canonical babbling ratio

    12 months

  • Canonical babbling; 3.Consonant inventory

    12 months

  • Articulation: 1. Percent consonant correct (PCC)

    3 and 5 years

  • +11 more secondary outcomes

Study Arms (2)

12 month surgery

EXPERIMENTAL

Infants will receive primary surgery at age 12 months using Sommerlad technique

Procedure: primary surgery for cleft palate

6 month surgery

EXPERIMENTAL

Infants will receive primary surgery at age 6 months using Sommerlad technique.

Procedure: primary surgery for cleft palate

Interventions

primary surgery for cleft palatePROCEDURE

Surgery completed using the Sommerlad technique

12 month surgery6 month surgery

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants with isolated cleft palate
  • Medically fit for operation at 6 months, corrected for gestational age
  • Written informed proxy consent
  • One parent/carer a native language speaker in the country of residence

You may not qualify if:

  • Consent not obtained
  • b. Infants with syndromic cleft palate (except Van der Woude syndrome, which can be included if hearing is not affected) or severe developmental delay
  • Congenital sensorineural hearing loss or middle ear anomalies;
  • Variation in the anatomical presentation is such that the surgeon who will perform the procedure considers that one stage closure with the Sommerlad technique would be inappropriate;
  • Submucous cleft palate (defined by the classical triad of signs, bifid, uvula, bony defect of the hard palate, muscular diastasis, as described by Jensen et al (1988).
  • Where the language spoken at home is not the majority language in the country of residence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

University of Sao Paulo

Bauru, Brazil

Location

Århus Speech and Hearing Institute

Aarhus, Denmark

Location

Copenhagen Cleft Palate Centre

Copenhagen, Denmark

Location

Helse Bergen HF

Bergen, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Göteborg University

Gothenburg, Sweden

Location

University of Linköping

Linköping, Sweden

Location

Malmö University Hospital

Malmo, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Umeå University

Umeå, Sweden

Location

Uppsala University

Uppsala, Sweden

Location

Belfast Health and Social Care Trust

Belfast, United Kingdom

Location

Birmingham Children's NHS Foundation Trust

Birmingham, United Kingdom

Location

North Bristol NHS Foundation Trust

Bristol, United Kingdom

Location

Edinburgh Hospital for Sick Children

Edinburgh, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

Leeds University Hospitals NHS foundation Trust

Leeds, United Kingdom

Location

Alder Hey Children's NHS Foundation Trust

Liverpool, L12 2AP, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Newcastle University Hospitals NHs Foundation Trust

Newcastle, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, United Kingdom

Location

Salisbury District Hospital

Salisbury, United Kingdom

Location

Abertawe Bro Morgannwg University Health Board

Swansea, United Kingdom

Location

Related Publications (4)

  • Gamble C, Persson C, Willadsen E, Albery L, Soegaard Andersen H, Zattoni Antoneli M, Appelqvist M, Aukner R, Bodling P, Bowden M, Brunnegard K, Cairns G, Calladine S, Campbell L, Clayton-Smith J, Cooper R, Conroy E, El-Angbawi A, Kildegaard Emborg B, Enfalt Wikman J, Fitzpatrick B, Fukushiro AP, Guedes de Azevedo Bento Goncalves 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 NH, Phippen G, Alvarez Piazentin-Penna SH, Patrick K, Pliskin L, Rigby L, Semb G, Southby L, Sporre M, Bjorkman Taleman AS, Tangstad J, Trindade IEK, Underwood I, van Eeden S, Westberg LR, Williamson PR, Paciello Yamashita R, Munro K, Walsh T, Shaw W; TOPS Study Group. Timing of Primary Surgery for Cleft Palate. N Engl J Med. 2023 Aug 31;389(9):795-807. doi: 10.1056/NEJMoa2215162.

    PMID: 37646677DERIVED

  • Willadsen E, Cooper R, Conroy E, Gamble C, Albery L, Andersen H, Appelqvist M, Bodling P, Bowden M, Brunnegard K, Enfalt J, van Eeden S, Goncalves C, Fukushiro A, Jorgensen L, Lemvik J, Leturgie L, Liljerehn E, Lodge N, McMahon S, Miguel H, Patrick K, Phippen G, Piazentin-Penna S, Southby L, Taleman AS, Tangstad J, Yamashita R, Shaw W, Munro K, Walsh T, Persson C. Inter-rater reliability in classification of canonical babbling status based on canonical babbling ratio in infants with isolated cleft palate randomised to Timing of Primary Surgery for Cleft Palate (TOPS). Clin Linguist Phon. 2023 Jan 2;37(1):77-98. doi: 10.1080/02699206.2021.2012259. Epub 2022 Jan 31.

    PMID: 35100923DERIVED

  • Conroy EJ, Cooper R, Shaw W, Persson C, Willadsen E, Munro KJ, Williamson PR, Semb G, Walsh T, Gamble C; TOPS trial management group. A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan. Trials. 2021 Jan 4;22(1):5. doi: 10.1186/s13063-020-04886-y.

    PMID: 33397459DERIVED

  • Shaw W, Semb G, Lohmander A, Persson C, Willadsen E, Clayton-Smith J, Trindade IK, Munro KJ, Gamble C, Harman N, Conroy EJ, Weichart D, Williamson P. Timing Of Primary Surgery for cleft palate (TOPS): protocol for a randomised trial of palate surgery at 6 months versus 12 months of age. BMJ Open. 2019 Jul 11;9(7):e029780. doi: 10.1136/bmjopen-2019-029780.

    PMID: 31300507DERIVED

MeSH Terms

Conditions

Cleft PalateSpeech

Interventions

cyclopropapyrroloindole

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMouth AbnormalitiesMouth DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVerbal BehaviorCommunicationBehavior

Study Officials

  • Kevin J Munro

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Audiology

Study Record Dates

First Submitted

October 9, 2009

First Posted

October 12, 2009

Study Start

July 1, 2010

Primary Completion

August 1, 2020

Study Completion

March 26, 2021

Last Updated

August 13, 2021

Record last verified: 2021-08

Locations

BR(1)NO(2)SE(6)DK(2)GB(12)