An Investigation for the Optimal Timing of a Cleft Palate Repair

March 23, 2022 updated by: David Fisher, The Hospital for Sick Children
The effect of timing of cleft palate repair on speech development, velopharyngeal functioning, and facial growth remains unknown. The objective of this study is to determine the effectiveness of early palatal repair versus The Hospital for Sick Children (SickKids) routine palatal repair in isolated cleft palate patients by comparing speech development, velopharyngeal functioning and facial growth outcomes. The null hypothesis is no difference in speech development, velopharyngeal functioning and facial growth between early palatal repair and SickKids routine palatal repair in isolated cleft palate patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The goals of palatoplasty are to provide an intact palate and to create a normally functioning velopharyngeal mechanism as early as possible without hazard to other aspects of health and development. Two major criteria by which the success of cleft palate surgery is determined are subsequent speech development and facial growth. Therefore, the debate about timing of cleft palate surgery is focused on the need for early palatoplasty for speech purposes versus later palatoplasty to ensure undisturbed facial growth. A compromise solution to this controversy was proposed by Schweckendiek; the soft palate is repaired at an early age leaving the hard palate cleft unrepaired until later in life. The premise is that primary veloplasty will result in a functioning velopharyngeal mechanism for early speech development, while the unrepaired hard palate will allow unrestricted maxillary growth. The speech outcomes of patients who have undergone delayed stage palate repair have been addressed in several studies and case series. However, there is little evidence to support the benefits of delayed stage repair with respect to facial growth and speech development. Results from published studies have shown the speech results to be relatively poor and fistula rates as unacceptably high. These results have lead a vast majority of North American surgeons to favour primary one-stage repair. Yet, the optimum timing of primary palate repair remains unknown. No randomized control trials or prospective cohort studies have been conducted to address this question.

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 5 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infant diagnosed with non-syndromic isolated unrepaired cleft involving the secondary palate.
  • Between newborn and 5 months of age (pre-palate surgical assessment/ consultation.
  • Treated at SickKids.

Exclusion Criteria:

  • If they are non-Ontario residents;
  • If they have clinical features suggestive of an associated syndrome and/or an associated syndrome;
  • If they have Pierre Robin sequence;
  • If the palate repair cannot be performed before 15 months of age;
  • If the extent of clefting is limited to the primary palate or submucous cleft of the soft palate;
  • If the child have a combined cleft lip and palate diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A
Early Cleft Palate Repair (Age group 6-10 months)
Procedure: Palatoplasty
Routine palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids
Procedure: Palatoplasty
Palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids
ACTIVE_COMPARATOR: Group B
Sick Kids Routine cleft palate repair (age group 10-14 months)
Procedure: Palatoplasty
Routine palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids
Procedure: Palatoplasty
Palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome will be determined by the presence/absence of Velopharyngeal Insufficiency (VPI) at 5 years of age.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Surgical Complications: Surgical complications (i.e. fistula and dehiscence) will be evaluated between 6-8 weeks post-operatively and recorded.
Time Frame: 6-8 weeks post-op
6-8 weeks post-op
Feeding Assessment: A feeding assessment will be conducted pre-surgery (5 months of age) and post surgery (6-8 weeks post-operatively).
Time Frame: 6-8 weeks post-op
6-8 weeks post-op
Dental and Facial Growth Disturbances measured in patients with isolated secondary plate cleft by analysis of the severity of their malocclusion,and performing a lateral cephalometric analysis
Time Frame: 5 years of age, 11-13 years of age
5 years of age, 11-13 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: David M Fisher, MD, FRCSC, The Hospital for Sick Children, Toronto, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

October 23, 2008

First Submitted That Met QC Criteria

October 23, 2008

First Posted (ESTIMATE)

October 24, 2008

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000010915

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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