Trial Outcomes & Findings for Timing of Primary Surgery for Cleft Palate (NCT NCT00993551)
NCT ID: NCT00993551
Last Updated: 2026-09-02
Results Overview
Measured by the Velopharyngeal Composite Score (VPC sum), which is a sum of scores, based on three components: hypernasality, non-oral errors, and VPI symptoms. Each component is scored between 0 and 2. The sum of the three scores gives the VPC sum (0-6). Scores ≥ 4 on this scale are considered insufficient (higher scores indicate a worse outcome). This outcome is measured as a dichotomous variable (insufficient or not insufficient) with a cut-off threshold of ≥ 4 to indicate insufficient. We report this as a percentage of participants that are assessed as having insufficient velopharyngeal function.
COMPLETED
NA
558 participants
5 years of age
2026-09-02
Participant Flow
Participant milestones
| Measure |
6 Month Surgery
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
12 Month Surgery
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Overall Study
STARTED
|
281
|
277
|
|
Overall Study
COMPLETED
|
235
|
226
|
|
Overall Study
NOT COMPLETED
|
46
|
51
|
Reasons for withdrawal
| Measure |
6 Month Surgery
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
12 Month Surgery
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
19
|
21
|
|
Overall Study
no appointment due to COVID
|
7
|
8
|
|
Overall Study
recording not received
|
11
|
17
|
|
Overall Study
recording od insufficient quality
|
7
|
1
|
|
Overall Study
no consent to use collected data
|
2
|
4
|
Baseline Characteristics
Timing of Primary Surgery for Cleft Palate
Baseline characteristics by cohort
| Measure |
6 Month Surgery
n=279 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
12 Month Surgery
n=273 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
Total
n=552 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
below 6 months at randomisation
|
279 Participants
n=136 Participants
|
273 Participants
n=136 Participants
|
552 Participants
n=272 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=136 Participants
|
162 Participants
n=136 Participants
|
327 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=136 Participants
|
111 Participants
n=136 Participants
|
225 Participants
n=272 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=136 Participants
|
7 Participants
n=136 Participants
|
11 Participants
n=272 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
2 Participants
n=136 Participants
|
8 Participants
n=136 Participants
|
10 Participants
n=272 Participants
|
|
Race/Ethnicity, Customized
Race · Chinese
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race/Ethnicity, Customized
Race · Mixed
|
13 Participants
n=136 Participants
|
16 Participants
n=136 Participants
|
29 Participants
n=272 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
256 Participants
n=136 Participants
|
238 Participants
n=136 Participants
|
494 Participants
n=272 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
4 Participants
n=272 Participants
|
|
Race/Ethnicity, Customized
Race · Not stated
|
1 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
4 Participants
n=272 Participants
|
|
Region of Enrollment
Sweden
|
33 participants
n=136 Participants
|
36 participants
n=136 Participants
|
69 participants
n=272 Participants
|
|
Region of Enrollment
Norway
|
25 participants
n=136 Participants
|
24 participants
n=136 Participants
|
49 participants
n=272 Participants
|
|
Region of Enrollment
Brazil
|
83 participants
n=136 Participants
|
82 participants
n=136 Participants
|
165 participants
n=272 Participants
|
|
Region of Enrollment
Denmark
|
23 participants
n=136 Participants
|
22 participants
n=136 Participants
|
45 participants
n=272 Participants
|
|
Region of Enrollment
United Kingdom
|
117 participants
n=136 Participants
|
124 participants
n=136 Participants
|
241 participants
n=272 Participants
|
PRIMARY outcome
Timeframe: 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Measured by the Velopharyngeal Composite Score (VPC sum), which is a sum of scores, based on three components: hypernasality, non-oral errors, and VPI symptoms. Each component is scored between 0 and 2. The sum of the three scores gives the VPC sum (0-6). Scores ≥ 4 on this scale are considered insufficient (higher scores indicate a worse outcome). This outcome is measured as a dichotomous variable (insufficient or not insufficient) with a cut-off threshold of ≥ 4 to indicate insufficient. We report this as a percentage of participants that are assessed as having insufficient velopharyngeal function.
Outcome measures
| Measure |
12 Month Surgery
n=226 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=235 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Insufficient Velopharyngeal Function
|
34 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Measured by the Velopharyngeal Composite Score (VPC sum), which is a sum of scores, based on three components: hypernasality, non-oral errors, and VPI symptoms. Each component is scored between 0 and 2. The sum of the three scores gives the VPC sum (0-6). Higher scores indicate increased severity.
Outcome measures
| Measure |
12 Month Surgery
n=226 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=235 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Velopharyngeal Composite Score Summary (VPC Sum)
|
1.17 score on a scale
Standard Deviation 1.69
|
0.93 score on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: 3 & 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Velopharyngeal function (VPC rate) measured on a 3 point scale; insufficient, marginal or sufficient. Scale is dichotomised into insufficient or marginal/sufficient (with lower score indicating insufficient). Reported as percentage of participants with insufficient function.
Outcome measures
| Measure |
12 Month Surgery
n=223 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=236 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Insufficient Velopharyngeal Function
Outcome at 3 yrs
|
19 Participants
|
25 Participants
|
|
Insufficient Velopharyngeal Function
Outcome at 5yrs
|
20 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 3 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
The percentage of times that a target consonant uttered has a VPI symptom
Outcome measures
| Measure |
12 Month Surgery
n=215 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=218 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Velopharyngeal Insufficiency Symptoms
|
3.33 Percentage
Interval 0.0 to 13.3
|
3.33 Percentage
Interval 0.0 to 12.5
|
SECONDARY outcome
Timeframe: 1 year of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Presence of canonical babbling of syllables
Outcome measures
| Measure |
12 Month Surgery
n=242 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=242 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Canonical Babbling Present
|
154 Participants
|
204 Participants
|
SECONDARY outcome
Timeframe: 1 year of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
The proportion of times that a syllable produced is "canonical"
Outcome measures
| Measure |
12 Month Surgery
n=242 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=242 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Canonical Babbling Ratio
|
0.28 Proportion of canonical syllables
Standard Deviation 0.21
|
0.41 Proportion of canonical syllables
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: 1 year of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
The number of unique consonants produced
Outcome measures
| Measure |
12 Month Surgery
n=242 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=242 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Canonical Babbling Consonant Inventory
|
2.91 number of unique consonants produced
Standard Deviation 1.68
|
4.54 number of unique consonants produced
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: 3 and 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
The percentage of times that a target consonant is uttered correct
Outcome measures
| Measure |
12 Month Surgery
n=226 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=235 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Articulation: Percent Consonant Correct (PCC)
3 years of age
|
70 Percentage of target consonants correct
Interval 55.0 to 86.7
|
73.7 Percentage of target consonants correct
Interval 53.6 to 88.5
|
|
Articulation: Percent Consonant Correct (PCC)
5 years of age
|
88.9 Percentage of target consonants correct
Interval 77.8 to 94.4
|
88.9 Percentage of target consonants correct
Interval 77.8 to 97.2
|
SECONDARY outcome
Timeframe: 3 and 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Percentage of times that a target consonant has the correct place of articulation
Outcome measures
| Measure |
12 Month Surgery
n=226 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=235 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Articulation: Percent Correct Placement (PCP)
3 years
|
80.0 % of consonants correct placement
Interval 63.3 to 90.0
|
82.45 % of consonants correct placement
Interval 64.0 to 92.3
|
|
Articulation: Percent Correct Placement (PCP)
5 years
|
91.7 % of consonants correct placement
Interval 83.3 to 97.2
|
94.4 % of consonants correct placement
Interval 83.3 to 97.2
|
SECONDARY outcome
Timeframe: 3 and 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Percentage of times that a target consonant has the correct manner of articulation
Outcome measures
| Measure |
12 Month Surgery
n=226 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=235 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Articulation: Percent Correct Manner (PCM)
3 years
|
93.3 percentage of consonants correct
Interval 80.0 to 96.7
|
93.3 percentage of consonants correct
Interval 80.8 to 100.0
|
|
Articulation: Percent Correct Manner (PCM)
5 years
|
97.2 percentage of consonants correct
Interval 94.4 to 100.0
|
97.2 percentage of consonants correct
Interval 94.4 to 100.0
|
SECONDARY outcome
Timeframe: 3 and 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Percentage of times that a target consonant is realised as a non-oral error
Outcome measures
| Measure |
12 Month Surgery
n=226 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=235 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Articulation: Non-oral Consonant Errors
5 years
|
0 percentage of non oral errors
Interval 0.0 to 0.0
|
0 percentage of non oral errors
Interval 0.0 to 0.0
|
|
Articulation: Non-oral Consonant Errors
3 years
|
0.0 percentage of non oral errors
Interval 0.0 to 5.3
|
0.0 percentage of non oral errors
Interval 0.0 to 6.7
|
SECONDARY outcome
Timeframe: 3 and 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Percentage of times that a target consonant is realised as an oral error
Outcome measures
| Measure |
12 Month Surgery
n=226 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=235 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Articulation: Oral Consonant Errors
3 years
|
0.0 % of oral errors
Interval 0.0 to 3.6
|
0.0 % of oral errors
Interval 0.0 to 3.5
|
|
Articulation: Oral Consonant Errors
5 years
|
0 % of oral errors
Interval 0.0 to 2.8
|
0 % of oral errors
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 30 days postoperativelyPopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Assessment for presence (indicated as yes on a dichotomized scale of yes/no) of postoperative/long term complication of dehiscence reported as percentage.
Outcome measures
| Measure |
12 Month Surgery
n=255 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=265 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Postoperative/Long Term Complications: Dehiscence
|
23 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days postoperativelyPopulation: ITT
A dichotomous outcome of whether the child has a postoperative infection (indicated as yes on a dichotomized scale of yes/no) reported as a percentage
Outcome measures
| Measure |
12 Month Surgery
n=246 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=259 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Postoperative/Long Term Complications: Infection
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Measured by assessment for presence (yes on a dichotomised scale of yes/no) for evidence of fistula, reported as percentage
Outcome measures
| Measure |
12 Month Surgery
n=256 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=266 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Postoperative/Long Term Complications: Evidence of Fistula
|
33 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 1 year of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
A dichotomous outcome of whether the child has abnormal TEOAE, reported percentage of participants that were abnormal.
Outcome measures
| Measure |
12 Month Surgery
n=64 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=51 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Hearing Level: Abnormal Transient Otoacoustic Emission (TEOAE)
|
50 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 1 year of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
A dichotomous outcome of whether the child has abnormal sound field audiometry. Abnormal sound field audiometry is indicated by a measurement of \>30 dB HL for at least one of four frequencies tested: 500 Hz, 1000 Hz, 2000 Hz or 4000 Hz. Reported as percentage of participants with abnormal outcome.
Outcome measures
| Measure |
12 Month Surgery
n=173 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=174 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Hearing Level: Abnormal Soundfield Audiometry
|
87 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: 3 and 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
A dichotomous outcome of whether the child has abnormal pure tone audiometry. If testing by pure tone audiometry is not possible, sound field audiometry can be used in its place. Abnormal audiometry in at least one ear is indicated by a measurement of \>20 dB HL using the pure tone method, \>25 dB HL for sound field, for at least one of four frequencies tested: 500 Hz, 1000 Hz, 2000 Hz or 4000 Hz.Reported as percentage of participants with abnormal outcome.
Outcome measures
| Measure |
12 Month Surgery
n=184 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=195 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Hearing Level: Abnormal Puretone Audiometry in at Least One Ear.
3 years
|
101 Participants
|
94 Participants
|
|
Hearing Level: Abnormal Puretone Audiometry in at Least One Ear.
5 years
|
70 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: 3 and 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
A dichotomous outcome defined in the same way as Abnormal Puretone Audiometry in at least one ear. For participants who have both ears tested and both tested ears indicate abnormal audiometry. Reported as percentage of participants with abnormal outcome.
Outcome measures
| Measure |
12 Month Surgery
n=181 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=191 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Hearing Level: Abnormal Puretone Audiometry in Both Ears
3 years
|
32 Participants
|
30 Participants
|
|
Hearing Level: Abnormal Puretone Audiometry in Both Ears
5 years
|
31 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 3 and 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Severity of hearing loss is measured in better ear is categorised as normal, mild, moderate, severe or profound. Reported as percentage of participants with hearing outcome below normal
Outcome measures
| Measure |
12 Month Surgery
n=182 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=194 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Hearing Level: Severity of Better Ear
3 years
|
72 Participants
|
67 Participants
|
|
Hearing Level: Severity of Better Ear
5 years
|
21 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 1, 3 and 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Middle ear function is assessed by presence of flat line Tympanogram in at least one ear. Reported as percentage of particpants with abnormal finding consistent with middle ear effusion.
Outcome measures
| Measure |
12 Month Surgery
n=201 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=189 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Middle Ear Function: Flat Line Tympanogram in at Least One Ear
1 year
|
177 Participants
|
122 Participants
|
|
Middle Ear Function: Flat Line Tympanogram in at Least One Ear
3 years
|
95 Participants
|
109 Participants
|
|
Middle Ear Function: Flat Line Tympanogram in at Least One Ear
5 years
|
72 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: 1, 3 and 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Middle ear function is assessed by presence of flat line Tympanogram in both ears. Reported as percentage of participants with abnormal outcome.
Outcome measures
| Measure |
12 Month Surgery
n=197 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=173 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Middle Ear Function: Flat Line Tympanogram in Both Ears
1 year
|
158 Participants
|
96 Participants
|
|
Middle Ear Function: Flat Line Tympanogram in Both Ears
3 years
|
61 Participants
|
80 Participants
|
|
Middle Ear Function: Flat Line Tympanogram in Both Ears
5 years
|
39 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
The angle between soft tissue nasion, A point, and B point on a profile photograph. The unit of measure is angular degrees
Outcome measures
| Measure |
12 Month Surgery
n=180 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=181 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Dentofacial Development: Soft Tissue ANB
|
8.6 Units in degrees
Standard Deviation 2.4
|
8.6 Units in degrees
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 5 years of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Maxillary arch constriction score: a bounded continuous outcome, measured using the Huddart/Bodenham scoring system, on a maxilliary and mandibular arches impression. A score can range from -24 to 8. A positive score is good, with negative scores indicating maxillary constriction.
Outcome measures
| Measure |
12 Month Surgery
n=172 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=188 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Dentofacial Development: Maxillary Arch Constriction Score
|
-1.6 score on a scale
Standard Deviation 3.7
|
-2.6 score on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: 1 year of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Growth: Nude weight measured in kg
Outcome measures
| Measure |
12 Month Surgery
n=241 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=236 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Growth: Nude Weight
|
9.5 kg
Standard Deviation 1.1
|
9.5 kg
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: 1 year of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Measured in centimetres and recorded to one decimal place.
Outcome measures
| Measure |
12 Month Surgery
n=237 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=238 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Growth: Crown to Heel Length
|
75.1 cm
Standard Deviation 3.1
|
75.1 cm
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 1 year of agePopulation: Participants with outcomes observed were analyzed in the group to which they were randomly allocated
Measured in centimetres and recorded to one decimal place.
Outcome measures
| Measure |
12 Month Surgery
n=235 Participants
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
6 Month Surgery
n=234 Participants
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
Growth: Occiptofrontal Circumference
|
46.3 cm
Standard Deviation 1.7
|
46.4 cm
Standard Deviation 1.8
|
Adverse Events
6 Month Surgery
12 Month Surgery
Serious adverse events
| Measure |
6 Month Surgery
n=259 participants at risk
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
12 Month Surgery
n=262 participants at risk
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate: Surgery completed using the Sommerlad technique
|
|---|---|---|
|
General disorders
Poor feeding
|
0.39%
1/259 • Number of events 1 • 48 hours and 30 days postoperatively, 3 and 5 years of age
Dehiscence, Infection and Fistula are reported as trial secondary outcomes
|
0.00%
0/262 • 48 hours and 30 days postoperatively, 3 and 5 years of age
Dehiscence, Infection and Fistula are reported as trial secondary outcomes
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstructive features
|
0.39%
1/259 • Number of events 1 • 48 hours and 30 days postoperatively, 3 and 5 years of age
Dehiscence, Infection and Fistula are reported as trial secondary outcomes
|
0.00%
0/262 • 48 hours and 30 days postoperatively, 3 and 5 years of age
Dehiscence, Infection and Fistula are reported as trial secondary outcomes
|
|
General disorders
anaphylactic shock
|
0.00%
0/259 • 48 hours and 30 days postoperatively, 3 and 5 years of age
Dehiscence, Infection and Fistula are reported as trial secondary outcomes
|
0.38%
1/262 • Number of events 1 • 48 hours and 30 days postoperatively, 3 and 5 years of age
Dehiscence, Infection and Fistula are reported as trial secondary outcomes
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway infection
|
0.39%
1/259 • Number of events 1 • 48 hours and 30 days postoperatively, 3 and 5 years of age
Dehiscence, Infection and Fistula are reported as trial secondary outcomes
|
0.00%
0/262 • 48 hours and 30 days postoperatively, 3 and 5 years of age
Dehiscence, Infection and Fistula are reported as trial secondary outcomes
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place