An Investigation for the Optimal Timing of a Cleft Palate Repair

The Hospital for Sick Children

Status

Unknown

Conditions

Cleft Palate

Treatments

Procedure: Palatoplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT00779961

1000010915

Details and patient eligibility

About

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.

Full 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.

Enrollment

320 estimated patients

Sex

All

Ages

1 day to 5 months old

Volunteers

No Healthy Volunteers

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