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Timing of Primary Surgery for Cleft Palate

NCT00993551 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2021-08-13

No results posted yet for this study

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.

Conditions

  • Cleft Palate

Interventions

PROCEDURE

primary surgery for cleft palate

Surgery completed using the Sommerlad technique

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • University of Copenhagen

    collaborator OTHER

  • Göteborg University

    collaborator OTHER

  • Kevin Munro

    lead OTHER

Principal Investigators

  • Kevin J Munro · University of Manchester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2020-08-31
Completion
2021-03-26

Countries

  • Brazil
  • Denmark
  • Norway
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00993551 on ClinicalTrials.gov