ClinicalTrials.gov
ClinicalTrials.gov Menu

An Investigation for the Optimal Timing of a Cleft Palate Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00779961
Recruitment Status : Unknown
Verified October 2008 by The Hospital for Sick Children.
Recruitment status was:  Recruiting
First Posted : October 24, 2008
Last Update Posted : October 24, 2008
Sponsor:
Information provided by:
The Hospital for Sick Children

October 23, 2008
October 24, 2008
October 24, 2008
April 2008
April 2011   (Final data collection date for primary outcome measure)
The primary outcome will be determined by the presence/absence of Velopharyngeal Insufficiency (VPI) at 5 years of age. [ Time Frame: 5 years ]
Same as current
No Changes Posted
  • 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 ]
  • 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 ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
An Investigation for the Optimal Timing of a Cleft Palate Repair
An Investigation for the Optimal Timing of a Cleft Palate Repair
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.
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.
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cleft Palate
  • 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
  • Experimental: Group A
    Early Cleft Palate Repair (Age group 6-10 months)
    Intervention: Procedure: Palatoplasty
  • Active Comparator: Group B
    Sick Kids Routine cleft palate repair (age group 10-14 months)
    Intervention: Procedure: Palatoplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
320
Same as current
April 2013
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 5 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00779961
1000010915
No
Not Provided
Not Provided
David M Fisher MD, FRCSC, FACS, The Hospital for Sick Children, Toronto, Canada
The Hospital for Sick Children
Not Provided
Principal Investigator: David M Fisher, MD, FRCSC The Hospital for Sick Children, Toronto, Canada
The Hospital for Sick Children
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP