An Investigation for the Optimal Timing of a Cleft Palate Repair

NCT00779961 | Unknown

• 1 other identifier: 1000010915
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cleft Palate

Keywords

pediatric; cleft palate; plastic surgery; palatoplasty; pharyngoplasty

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be determined by the presence/absence of Velopharyngeal Insufficiency (VPI) at 5 years of age.

  5 years

Secondary Outcomes (3)

• Surgical Complications: Surgical complications (i.e. fistula and dehiscence) will be evaluated between 6-8 weeks post-operatively and recorded.

  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).

  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

  5 years of age, 11-13 years of age

Study Arms (2)

Group A

EXPERIMENTAL

Early Cleft Palate Repair (Age group 6-10 months)

Procedure: Palatoplasty

Group B

ACTIVE COMPARATOR

Sick Kids Routine cleft palate repair (age group 10-14 months)

Procedure: Palatoplasty

Interventions

Palatoplasty PROCEDURE

Routine palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids

Group A

Eligibility Criteria

• Age: 1 Day - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David M Fisher, MD, FRCSC

  The Hospital for Sick Children, Toronto, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director and Surgeon

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

CA (1)