Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty

Study Overview
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Brief Summary
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Early neonatal cheiloplasty is modified surgery protocol applied in the first week of newborn's life used for treating orofacial cleft patients. This prospective study analyzes the effects of early neonatal cheiloplasty on the growth and development of maxilla and palate during the observed period of one year.

Detailed Description
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Multidisciplinary treatment of patients with orofacial clefts begins immediately after birth. The first surgical procedure is early neonatal cheiloplasty applied in the first week of the newborn's life, which has been practiced in the Czech Republic for many years. It is a popular parental choice and has a lot of benefits compared to classic cheiloplasty performed between 3-6 months. Unrestricted growth of jaws is essential for the successful therapy of aesthetics and functions. Although there are known a lot of benefits to this surgery, its influence on facial growth is still being studied. The methodology of this study is based on modern three-dimensional imaging methods and will be evaluated by classic and geometric morphometric analysis of virtual dental models. The existing database includes 137 virtual dental casts (complete and incomplete bilateral or unilateral cleft lip and palate). The main aim is to verify that the effects of early neonatal cheiloplasty on the facial or palatal growth are minimal in affected individuals and therefore the subsequent development of these structures can be predicted at a later age. Other goals are to evaluate palatal morphology before and one year after early neonatal cheiloplasty, to assess growth of maxilla and palate using classic and geometric morphometry, to assess morphological differences between cleft types and to compare the results with previously published data of neonates operated by later operation protocol and noncleft control groups.

Official Title
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Three-dimensional Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty: Classic and Geometric Morphometric Evaluation

Conditions
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Cleft Palate, Cleft Lip, Cleft Lip and Palate, Cleft Lip, Bilateral

Intervention / Treatment
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* Procedure: Early neonatal cheiloplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nonsyndromic orofacial cleft Czech origin Operated by the same surgeon Following same surgery protocol (modified Veau surgery protocol) Excellent body temperature, blood pressure, oxygen saturation, heart function Performing of early neonatal cheiloplasty Exclusion Criteria: Poor health Syndromic orofacial cleft Operated by later operation protocol (3-6 months) Non-Czech origin

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bilateral cleft lip and palate patients<br>Newborns with complete bilateral cleft lip and palate (cBCLP) and bilateral cleft lip and palate with tissue bridges (BCLP + B) analyzed one year after neonatal cheiloplasty | Procedure: Early neonatal cheiloplasty<br> <br> |
| Unilateral cleft lip and palate patients<br>Newborns with complete unilateral cleft lip and palate (cUCLP) and unilateral cleft lip and palate with tissue bridges (UCLP + B) analyzed one year after neonatal cheiloplasty | Procedure: Early neonatal cheiloplasty<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth changes during the first year of life | Analysis of palatal growth changes in individuals with orofacial clefts after neonatal cheiloplasty (5 ± 5 days) and before palatoplasty (12 ± 6 months). | T0 before early neonatal cheiloplasty (5 ± 5 days) and T1 before palatoplasty (12 ± 6 months). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the palatal growth in orofacial cleft patients | Comparison of the growth of the palate in complete and incomplete cleft patients | 1 year | 
| Differences between cleft types | Morphological differences between complete and incomplete cleft types | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bilateral cleft lip and palate, unilateral cleft lip and palate, 3D geometric morphometrics, upper dental arch, classical morphometrics, early neonatal cheiloplasty