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:
Kevin Munro
Organization:
Study Overview
Official Title:
Timing of Primary Surgery for Cleft Palate
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOPS
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.
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.
Detailed Description:
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
Age 5 Years
* Speech development
* Audiological assessments
* Dentofacial development (Soft Tissue ANB and Maxillary arch constriction score using modified Huddart Bodenham scoring)
Age 12 months
* Speech development (canonical babbling)
* Audiological assessments
* Growth
Age 3 years
* Speech development
* Audiological assessments
Age 5 Years
* Speech development
* Audiological assessments
* Dentofacial development (Soft Tissue ANB and Maxillary arch constriction score using modified Huddart Bodenham scoring)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1U01DE018837-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |
| Sponsor Reference: 57201 | OTHER | The University of Manchester (UK) | View | |
| NIHR Portfolio Reference 30200 | OTHER | NIHR | View |