Presurgical orthopedics and satisfaction in motherhood: a randomized clinical trial (Dutchcleft).

Contains fulltext : 71391.pdf (publisher's version ) (Closed access)OBJECTIVE: To study the effect of infant orthopedics on satisfaction in motherhood. DESIGN: Prospective two-arm randomized controlled trial in parallel with three participating academic cleft palate centers. Treatment allocation was concealed and was performed by means of a computerized balanced allocation method. Setting: Cleft palate centers of Amsterdam, Nijmegen, and Rotterdam, the Netherlands. PATIENTS: Two groups of infants with complete unilateral cleft lip and palate and no other malformations. INTERVENTIONS: Group IO+ (n = 27) wore passive maxillary plates during the first year of life, group IO- (n = 27) did not. MAIN OUTCOME MEASURE(S): Mean satisfaction scores were obtained from completed questionnaires at 6, 24, and 58 weeks of age. A 4-point scale was used (1 = very satisfactory to 4 = very unsatisfactory). RESULTS: The range of the mean scores for the individual items on the questionnaires for both groups ranged between 1.1 and 2.4. No differences were found between groups. Mothers appear to be satisfied in motherhood, least satisfied with the available time for themselves, and very satisfied with hugging and walking their babies. No differences were found between groups. CONCLUSIONS: Results from the present study show that infant orthopedics, with a passive plate during the first year of life, in children with a unilateral cleft lip and palate has no influence on the mothers' satisfaction in motherhood

Effect of infant orthopedics on facial appearance of toddlers with complete unilateral cleft lip and palate (Dutchcleft).

Contains fulltext : 70434.pdf (publisher's version ) (Closed access)OBJECTIVE: To evaluate the effect of infant orthopedics (IO) on facial appearance of 54 patients with unilateral cleft lip and palate (UCLP), aged 4 and 6 years. DESIGN: Prospective two-arm randomized controlled clinical trial in three Cleft Palate Centers in the Netherlands (Dutchcleft-trial). INTERVENTIONS: Patients were divided randomly into two groups. Half of the patients (IO+) had a plate until surgical closure of the soft palate at the age of +/- 52 weeks; the other half (IO-) received no intervention. MAIN OUTCOME MEASURES: Facial appearance at 4 and 6 years of age assessed on full face photographs and photographs showing only nose and mouth. Ratings were performed on a VAS-scale by professionals and laymen. RESULTS: At 4 years of age the full face pictures of IO+ children were scored to be more attractive than those of IO- children. However, this difference had disappeared at 6 years of age. At the age of 6, only professionals saw a significant difference on nasolabial photographs between IO+ and IO-. Regression analysis showed a minor effect of occlusion, lip revision, or type of nose reconstruction on the esthetic results. CONCLUSIONS: IO had a positive effect on full facial appearance of UCLP children at the age of 4 years, but at the age of 6, only professionals saw a positive effect of IO on the nasolabial photographs. This is irrelevant for UCLP patients since they deal with laymen in their daily life

Cost-effectiveness of infant orthopedic treatment regarding speech in patients with complete unilateral cleft lip and palate: a randomized three-center trial in the Netherlands (Dutchcleft).

Contains fulltext : 57384.pdf (publisher's version ) (Closed access)OBJECTIVE: To investigate the cost-effectiveness of infant orthopedic treatment (IO), compared with no such treatment in children with complete unilateral cleft lip and palate (UCLP) focusing on the effects on speech development at age 2.5 years. DESIGN: In a three-center prospective, randomized clinical trial (Dutchcleft), two groups of children with complete UCLP were followed longitudinally: one group was treated with IO based on a modified Zurich approach in the first year of life (IO group) and the other group did not receive this treatment (non-IO group). PATIENTS: The participants had complete UCLP without soft tissue bands or other malformations. They were born at term and their parents were native Dutch speakers. OUTCOME MEASURES: The effect of IO on speech development at age 2.5 years was measured blindly by five expert listeners judging the "total impression of speech quality" on a 10-point equal-appearing interval scale. Costs were measured from a societal viewpoint in Euro. RESULTS AND CONCLUSION: The IO group (n = 10) obtained a statistically significant higher rating, compared with the non-IO group (n = 10). The effect size was large, indicating that the improvement may be considered a clinically important change. The cost for treatment by the orthodontist was higher in the IO group. For both groups, the mean cost was related to the mean rating for "total impression of speech quality." The resulting cost-effectiveness for IO, compared to non-IO was 1041 for 1.34 point speech quality improvement. The financial investment that is necessary to obtain this improvement seems limited. Thus, from the perspective of speech development, the cost-effectiveness of IO over non-IO seems acceptable at this point in time