Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-06 @ 2:28 AM
Study NCT ID:
NCT00993551
Status:
COMPLETED
Last Update Posted:
2021-08-13
First Post:
2009-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timing of Primary Surgery for Cleft Palate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-05-26', 'releaseDate': '2023-05-02'}], 'estimatedResultsFirstSubmitDate': '2023-05-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002972', 'term': 'Cleft Palate'}, {'id': 'D013060', 'term': 'Speech'}], 'ancestors': [{'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C110747', 'term': 'cyclopropapyrroloindole'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 558}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-06', 'studyFirstSubmitDate': '2009-10-09', 'studyFirstSubmitQcDate': '2009-10-09', 'lastUpdatePostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure for the TOPS trial is insufficient velopharyngeal function.', 'timeFrame': '5 years', 'description': 'Unit of measure: Sufficient (VPC sum \\<=3) or insufficient (VPC sum\\>=4). VPC sum measured on scale from 1 to 6.'}], 'secondaryOutcomes': [{'measure': 'Velopharyngeal function;1.Velopharyngeal composite score summary (VPC sum) 2.Insufficient velopharyngeal function (VPC rate)', 'timeFrame': '3 and 5 years', 'description': 'Velopharyngeal function measured by combination of VPC sum and VPC rate. VPC sum is measured as for primary outcome measure and VPC rate on a 3 point scale; insufficient, marginal or sufficient'}, {'measure': 'Velopharyngeal function: Velopharyngeal insufficiency symptoms', 'timeFrame': '3 years', 'description': 'It will be measured either by presence of resonance "yes" within normal limit or "no" if not within normal limit'}, {'measure': 'Canonical babbling; 1.Canonical babbling present 2.Canonical babbling ratio', 'timeFrame': '12 months', 'description': 'Canonical babbling is measured by presence of vocalised syllables and percentage ( ratio) of children vocalising canonical or non canonical babbling of syllables'}, {'measure': 'Canonical babbling; 3.Consonant inventory', 'timeFrame': '12 months', 'description': 'Consonant inventory is measured by the number of correct sounds produced'}, {'measure': 'Articulation: 1. Percent consonant correct (PCC)', 'timeFrame': '3 and 5 years', 'description': 'Articulation is measured by the percentage of children vocalising the correct consonants'}, {'measure': 'Articulation: 1.Percent Correct Placement (PCP) 3. Percent Correct Manner (PCM) 4. Non-oral consonant errors 5. Oral consonant errors', 'timeFrame': '3 and 5 years', 'description': 'Articulation is measured by the percentage of children vocalising correct consonants ( oral and non-oral) in the correct placement and manner'}, {'measure': 'Postoperative/long term complications', 'timeFrame': '48 hours and 30 days postoperatively', 'description': 'Complications are measured by assessment for presence (yes or no) of the following:1.Dehiscence 2.Infection 3.Evidence of fistula'}, {'measure': 'Postoperative/long term complications', 'timeFrame': 'at 3 and 5 year follow up', 'description': 'measured by assessment for presence (yes or no) or evidence of fistula'}, {'measure': 'Hearing: hearing level assessment', 'timeFrame': '12 months', 'description': 'Assessment of hearing level by Tympanometry and abnormal transient otoacoustic emission (TEOAE)'}, {'measure': 'Hearing level assessment for: 1. Abnormal Puretone audiometry in one and or both ears.', 'timeFrame': '3 and 5 years', 'description': 'Hearing level is assessed by Puretone audiometry'}, {'measure': 'Hearing level assessment', 'timeFrame': '3 and 5 years', 'description': 'Severity of hearing loss is measured in better ear is categorised as normal, mild, moderate, severe or profound.'}, {'measure': 'Middle ear function', 'timeFrame': '12 months, 3 and 5 years', 'description': 'Middle ear function is assessed by presence of flat line Tympanogram in at least one ear and or both ears'}, {'measure': 'Dentofacial development: Soft tissue ANB (the angle between soft tissue nasion,', 'timeFrame': '5 years', 'description': 'Soft tissue development is measured by measuring the angle between two points (SSs-ns-sms) on a profile photograph. The unit of measure is angular degrees'}, {'measure': 'Dentofacial development; Maxillary arch constriction score', 'timeFrame': '5 years', 'description': 'This outcome is assesed using modified Huddart/Bodenham scoring system which is a range from -24 to +8'}, {'measure': 'Growth assessment for nude weight', 'timeFrame': '12 months', 'description': 'Growth is measured in Kg body weight in nude'}, {'measure': 'Growth Assessment for crown to heel length and occipitofrontal circumference', 'timeFrame': '12 months', 'description': 'Assessment for crown to heel length and Occipitofrontal circumference are in centimetres.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cleft palate', 'paediatric', 'pediatric', 'surgery', 'speech', 'velopharyngeal'], 'conditions': ['Cleft Palate']}, 'referencesModule': {'references': [{'pmid': '37646677', 'type': 'DERIVED', 'citation': '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': '35100923', 'type': 'DERIVED', 'citation': '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': '33397459', 'type': 'DERIVED', 'citation': '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': '31300507', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This trial is a randomised controlled trial with a parallel design taking place in centres across the UK, Scandinavia and Brazil.\n\n650 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:\n\n* Surgery at age 6 months, OR\n* Surgery at age 12 months.\n\nThe 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.', 'detailedDescription': 'Infants will be followed up at age 12 months, 3 years and five years. At each visit the following will be assessed:\n\nAge 12 months\n\n* Speech development (canonical babbling)\n* Audiological assessments\n* Growth\n\nAge 3 years\n\n* Speech development\n* Audiological assessments\n\nAge 5 Years\n\n* Speech development\n* Audiological assessments\n* Dentofacial development (Soft Tissue ANB and Maxillary arch constriction score using modified Huddart Bodenham scoring)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants with isolated cleft palate\n* Medically fit for operation at 6 months, corrected for gestational age\n* Written informed proxy consent\n* One parent/carer a native language speaker in the country of residence\n\nExclusion Criteria:\n\n* Consent not obtained\n* b. Infants with syndromic cleft palate (except Van der Woude syndrome, which can be included if hearing is not affected) or severe developmental delay\n* Congenital sensorineural hearing loss or middle ear anomalies;\n* 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;\n* 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).\n* Where the language spoken at home is not the majority language in the country of residence.'}, 'identificationModule': {'nctId': 'NCT00993551', 'acronym': 'TOPS', 'briefTitle': 'Timing of Primary Surgery for Cleft Palate', 'organization': {'class': 'OTHER', 'fullName': 'University of Manchester'}, 'officialTitle': 'Timing of Primary Surgery for Cleft Palate', 'orgStudyIdInfo': {'id': '09-017-E'}, 'secondaryIdInfos': [{'id': '1U01DE018837-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1U01DE018837-01A1', 'type': 'NIH'}, {'id': 'Sponsor Reference: 57201', 'type': 'OTHER', 'domain': 'The University of Manchester (UK)'}, {'id': 'NIHR Portfolio Reference 30200', 'type': 'OTHER', 'domain': 'NIHR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '12 month surgery', 'description': 'Infants will receive primary surgery at age 12 months using Sommerlad technique', 'interventionNames': ['Procedure: primary surgery for cleft palate']}, {'type': 'EXPERIMENTAL', 'label': '6 month surgery', 'description': 'Infants will receive primary surgery at age 6 months using Sommerlad technique.', 'interventionNames': ['Procedure: primary surgery for cleft palate']}], 'interventions': [{'name': 'primary surgery for cleft palate', 'type': 'PROCEDURE', 'description': 'Surgery completed using the Sommerlad technique', 'armGroupLabels': ['12 month surgery', '6 month surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bauru', 'country': 'Brazil', 'facility': 'University of Sao Paulo', 'geoPoint': {'lat': -22.31472, 'lon': -49.06056}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Århus Speech and Hearing Institute', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen Cleft Palate Centre', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Bergen', 'country': 'Norway', 'facility': 'Helse Bergen HF', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Göteborg University', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Linköping', 'country': 'Sweden', 'facility': 'University of Linköping', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'Malmö University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Umeå', 'country': 'Sweden', 'facility': 'Umeå University', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Belfast Health and Social Care Trust', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': "Birmingham Children's NHS Foundation Trust", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'North Bristol NHS Foundation Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Edinburgh Hospital for Sick Children', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'NHS Greater Glasgow and Clyde', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds University Hospitals NHS foundation Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'L12 2AP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': "Alder Hey Children's NHS Foundation Trust", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester University NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Newcastle University Hospitals NHs Foundation Trust', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Salisbury', 'country': 'United Kingdom', 'facility': 'Salisbury District Hospital', 'geoPoint': {'lat': 51.06931, 'lon': -1.79569}}, {'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Abertawe Bro Morgannwg University Health Board', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}], 'overallOfficials': [{'name': 'Kevin J Munro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manchester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kevin Munro', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Liverpool', 'class': 'OTHER'}, {'name': 'National Institute of Dental and Craniofacial Research (NIDCR)', 'class': 'NIH'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'Göteborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Audiology', 'investigatorFullName': 'Kevin Munro', 'investigatorAffiliation': 'University of Manchester'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-05-02', 'type': 'RELEASE'}, {'date': '2023-05-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Kevin Munro, Professor of Audiology, University of Manchester'}}}}