Objective: To investigate in-depth speech results in the Scandcleft Trial 2
with comparisons between surgical protocols and centers, and with
benchmarks from peers without cleft palate.
Design: A prospective randomized clinical trial
Setting: Two Swedish and one Finnish Cleft Palate center.
Participants: The 112 participants were 5-year-old born with unilateral
cleft lip and palate randomized to either lip repair and soft palate closure
at 4 months, and hard palate closure at 12 months or lip repair at 3-4
months (Arm A) or a closure of both the soft and hard palate at 12
months (Arm C).
Main outcome measures: A composite measure dichotomized into
velopharyngeal competency (VPC) or velopharyngeal incompetency
(VPI), overall assessment of velopharyngeal function (VPC-Rate),
Percentage of Consonants Correct (PCC-score), and consonant errors. In
addition, number of speech therapy visits, average hearing thresholds,
and secondary surgeries were documented to assess burden of
treatment.
Results: Across the trial 53.5% demonstrated VPC and 46.5% VPI with
no significant differences between arms or centers. In total, 27%
reached age appropriate PCC-scores with no statistically significant
difference between the arms. The Finnish center had significantly higher
PCC-scores, the Swedish centers higher percentages of oral consonant
errors. Number of speech therapy visits was significantly higher in the
Finnish center.
Conclusion: At age 5, poor speech outcomes with some differences
between participating centers were seen but could not be attributed to
surgical protocol. As one center had very few participants, the results
from that center should be interpreted with caution.
Trial registration: ISRCTN29932826