Timing of Primary Surgery for Cleft Palate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 558
- 试验地点
- 27
- 主要终点
- The primary outcome measure for the TOPS trial is insufficient velopharyngeal function.
研究概览
简要总结
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.
详细描述
Infants will be followed up at age 12 months, 3 years and five years. At each visit the following will be assessed:
Age 12 months
- Speech development (canonical babbling)
- Audiological assessments
- Growth
Age 3 years
- Speech development
- Audiological assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
6 month surgery
Infants will receive primary surgery at age 6 months using Sommerlad technique.
干预措施: primary surgery for cleft palate (Procedure)
12 month surgery
Infants will receive primary surgery at age 12 months using Sommerlad technique
干预措施: primary surgery for cleft palate (Procedure)
结局指标
主要结局
The primary outcome measure for the TOPS trial is insufficient velopharyngeal function.
时间窗: 5 years
Unit of measure: Sufficient (VPC sum \<=3) or insufficient (VPC sum\>=4). VPC sum measured on scale from 1 to 6.
Insufficient Velopharyngeal Function
时间窗: 5 years of age
Measured by the Velopharyngeal Composite Score (VPC sum), which is a sum of scores, based on three components: hypernasality, non-oral errors, and VPI symptoms. Each component is scored between 0 and 2. The sum of the three scores gives the VPC sum (0-6). Scores ≥ 4 on this scale are considered insufficient (higher scores indicate a worse outcome). This outcome is measured as a dichotomous variable (insufficient or not insufficient) with a cut-off threshold of ≥ 4 to indicate insufficient. We report this as a percentage of participants that are assessed as having insufficient velopharyngeal function.
次要结局
- Hearing level assessment(3 and 5 years)
- Hearing: hearing level assessment(12 months)
- 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)
- Articulation: 1.Percent Correct Placement (PCP) 3. Percent Correct Manner (PCM) 4. Non-oral consonant errors 5. Oral consonant errors(3 and 5 years)
- Postoperative/long term complications(at 3 and 5 year follow up)
- 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)
- Hearing level assessment for: 1. Abnormal Puretone audiometry in one and or both ears.(3 and 5 years)
- Middle ear function(12 months, 3 and 5 years)
- Dentofacial development: Soft tissue ANB (the angle between soft tissue nasion,(5 years)
- Growth assessment for nude weight(12 months)
- Dentofacial development; Maxillary arch constriction score(5 years)
- Growth Assessment for crown to heel length and occipitofrontal circumference(12 months)
- Dentofacial Development: Soft Tissue ANB(5 years of age)
- Dentofacial Development: Maxillary Arch Constriction Score(5 years of age)
- Growth: Nude Weight(1 year of age)
- Growth: Crown to Heel Length(1 year of age)
- Growth: Occiptofrontal Circumference(1 year of age)
- Velopharyngeal Composite Score Summary (VPC Sum)(5 years of age)
- Insufficient Velopharyngeal Function(3 & 5 years of age)
- Velopharyngeal Insufficiency Symptoms(3 years of age)
- Canonical Babbling Present(1 year of age)
- Canonical Babbling Ratio(1 year of age)
- Canonical Babbling Consonant Inventory(1 year of age)
- Articulation: Percent Consonant Correct (PCC)(3 and 5 years of age)
- Articulation: Percent Correct Placement (PCP)(3 and 5 years of age)
- Articulation: Percent Correct Manner (PCM)(3 and 5 years of age)
- Articulation: Non-oral Consonant Errors(3 and 5 years of age)
- Articulation: Oral Consonant Errors(3 and 5 years of age)
- Postoperative/Long Term Complications: Dehiscence(Up to 30 days postoperatively)
- Postoperative/Long Term Complications: Infection(Up to 30 days postoperatively)
- Postoperative/Long Term Complications: Evidence of Fistula(Up to 5 years of age)
- Hearing Level: Abnormal Transient Otoacoustic Emission (TEOAE)(1 year of age)
- Hearing Level: Abnormal Soundfield Audiometry(1 year of age)
- Hearing Level: Abnormal Puretone Audiometry in at Least One Ear.(3 and 5 years of age)
- Hearing Level: Abnormal Puretone Audiometry in Both Ears(3 and 5 years of age)
- Hearing Level: Severity of Better Ear(3 and 5 years of age)
- Middle Ear Function: Flat Line Tympanogram in at Least One Ear(1, 3 and 5 years of age)
- Middle Ear Function: Flat Line Tympanogram in Both Ears(1, 3 and 5 years of age)
研究者
Kevin Munro
Professor of Audiology
University of Manchester