Charlotte Prahl

A Randomized Prospective Clinical Trial of the Effect of Infant Orthopedics in Unilateral Cleft Lip and Palate: Prevention of Collapse of the Alveolar Segments (Dutchcleft)

OBJECTIVE To study the effect of infant orthopedics (IO) on maxillary arch form and position of the alveolar segments. DESIGN Prospective two-arm randomized, controlled trial in parallel with three participating academic cleft palate centers. Treatment was assigned by means of a computerized balanced allocation method. SETTING Cleft palate centers of Amsterdam, Nijmegen, and Rotterdam, the Netherlands. PATIENTS, PARTICIPANTS Infants with complete unilateral cleft lip and palate and no other malformations. INTERVENTIONS One group (IO+) wore passive maxillary plates during the first year of life; the other group (IO-) did not. All other interventions were the same. MAIN OUTCOME MEASURE(S) The presence of contact and/or overlap (collapse) between the maxillary segments at maxillary casts made shortly after birth, at 15, 24, 48, 58, and 78 weeks. Survival experience of contact and collapse with time as well as the frequencies of different arch forms and severity of collapse were evaluated. RESULTS Comparable arch forms with no contact or overlap of the maxillary segments were seen at birth in both groups. With time the frequency of collapse increased, with no significant differences between groups. No significant group differences were found with respect to the survival experience of contact and collapse or for the severity of collapse at the end of the observational period. CONCLUSIONS Infant orthopedics does not prevent collapse and can be abandoned as a tool to improve maxillary arch form.

Infant orthopedics in UCLP: effect on feeding, weight, and length: a randomized clinical trial (Dutchcleft)

Objective To study the effects of infant orthopedics (IO) on feeding, weight, and length. Design Prospective two-arm randomized controlled trial in three academic Cleft Palate Centers. Treatment allocation was concealed and performed by means of a computerized balanced allocation method. Setting Cleft Palate Centers of Amsterdam, Nijmegen, and Rotterdam, the Netherlands. Patients Infants with complete unilateral cleft lip and palate (UCLP), no other malformations. Interventions One group (IO+) wore passive maxillary plates during the first year of life, but the other group (IO−) did not. All other interventions were the same for both groups. Main Outcome Measures Bottle feeding velocity (mL/min) at intake, 3, 6, 15, and 24 weeks (T0 to T24); weight-for-age, length-for-age, and weight-for-length using z scores; reference values from the Netherlands’ third nationwide survey on growth. Results Feeding velocity increased with time from 2.9 to 13.2 mL/min in the IO− group and from 2.6 to 13.8 mL/min in the IO+ group; no significant differences were found between groups. Weight-for-age, length-for-age, and weight-for-length (z scores) did not differ significantly between groups, but overall the infants with unilateral cleft lip and palate in both groups had significantly lower mean z scores for weight-for-age and height-for-age than the reference during the first 14 months, and had lower mean values for weight-for-length after soft palate closure. Conclusion Infant orthopedics with the aim of improving feeding and consequent nutritional status in infants with unilateral cleft lip and palate can be abandoned.

Short-term cost-effectiveness analysis of presurgical orthopedic treatment in children with complete unilateral cleft lip and palate

OBJECTIVE The aim of this article was to investigate cost-effectiveness in cleft palate treatment using cost-effectiveness of presurgical orthopedic treatment (PSOT) as an example. DESIGN A three-center randomized clinical trial compared PSOT with non-PSOT for children with unilateral cleft lip and palate (UCLP, n=52). PATIENTS The inclusion criteria for the trial were: complete UCLP, no other malformations, born at term, both parents Caucasian, trial entrance preferably within 2 weeks after birth, and informed consent by the parents. INTERVENTIONS PSOT was performed by means of a passive plate according to Hotz and Gnoinski. MAIN OUTCOME MEASURE The short-term cost-effectiveness of PSOT was based on the time taken for the surgical lip closure procedure. Medical and nonmedical costs until surgical lip closure at 18 weeks of age were analyzed. RESULTS The durations of the surgical lip closure procedures did not differ significantly (57.2 minutes for PSOT and 56.4 minutes for non-PSOT). The mean medical cost for PSOT treatment was US

Infant Orthopedics and Facial Growth in Complete Unilateral Cleft Lip and Palate Until Six Years of Age (Dutchcleft)

852. The non-PSOT treatment group had a significantly different mean medical cost (US

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).

304). Mean travel costs and indirect nonmedical costs were US

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

128 and US

The Asher-McDade Aesthetic Index in Comparison With Two Scoring Systems in Nonsyndromic Complete Unilateral Cleft Lip and Palate Patients.

231 for PSOT and US

Comparison of two scoring systems in the assessment of nasolabial appearance in cleft lip and palate patients

79 and US

The Development of the Cleft Aesthetic Rating Scale: A New Rating Scale for the Assessment of Nasolabial Appearance in Complete Unilateral Cleft Lip and Palate Patients.

130 for non-PSOT, respectively. CONCLUSIONS The combination of a clinical trial and an economic evaluation makes it possible to relate effects to costs involved in treatment alternatives. Longer-term costs and effects will be incorporated into an extended cost-effectiveness analysis to determine the cost-effectiveness of PSOT.

Two cases of axenfeld-rieger syndrome, report of the complex pathology and treatment.

Objective: To evaluate longitudinally the effect of infant orthopedics (IO) on dentofacial cephalometric variables in unilateral cleft lip and palate (UCLP) patients from 4 to 6 years of age. Design: Prospective two-arm randomized controlled clinical trial in three cleft palate centers in The Netherlands (Dutchcleft trial). Patients: Fifty-four children with complete UCLP. Interventions: Patients were divided randomly into two groups. Half of the patients (IO+) had IO until surgical closure of the soft palate at the age of ±52 weeks; the other half (IO−) received no intervention. Mean Outcome Measures: Cephalometric values representing soft tissue, hard tissue, and dental structures, measured on lateral headfilms made at 4 and 6 years of age. Results: In the IO+ group, 21 patients were analyzed; in the IO− group, 20 patients were analyzed at age 4 and 22 at age 6. No differences were found between IO+ and IO−, except for two measurements: The interincisal angle was larger and the mentolabial angle was smaller in the IO+ group. Conclusions: For infants with UCLP whose surgical management included soft palate repair at 12 months and delayed hard palate closure, cephalometric outcomes at ages 4 and 6 provide no indication for the type of IO used in this study.