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NCT03839290 Clinical Trial

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

Cleft Lip and Palate Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03839290
Other study ID # 656216
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2016
Est. completion date May 2019

Study information
Verified date February 2019
Source Charles University, Czech Republic
Contact Lenka Jaklová
Phone 723899485
Email jaklovale@natur.cuni.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 137
Est. completion date May 2019
Est. primary completion date May 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Early neonatal cheiloplasty

Locations
Country Name City State
Czechia Lenka Jaklová Praha Czech Republic

Sponsors (4)
Lead Sponsor Collaborator
Charles University, Czech Republic Anthropology and Human Genetics, Department of Newborns with Intensive Care Unit, Otorhinolaryngology, 2nd Faculty of Medicine

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

Hoffmannova E, Bejdová Š, Borský J, Dupej J, Cagánová V, Velemínská J. Palatal growth in complete unilateral cleft lip and palate patients following neonatal cheiloplasty: Classic and geometric morphometric assessment. Int J Pediatr Otorhinolaryngol. 2016 Nov;90:71-76. doi: 10.1016/j.ijporl.2016.08.028. Epub 2016 Aug 31. — View Citation

Hoffmannova E, Moslerová V, Dupej J, Borský J, Bejdová Š, Velemínská J. Three-dimensional development of the upper dental arch in unilateral cleft lip and palate patients after early neonatal cheiloplasty. Int J Pediatr Otorhinolaryngol. 2018 Jun;109:1-6. doi: 10.1016/j.ijporl.2018.03.009. Epub 2018 Mar 14. — View Citation

Jiri B, Jana V, Michal J, Jiri K, Dana H, Miroslav T, Milos C, Zdenek K, Jaroslav F, Jan J, Jiri Z, Renata P, Miroslav P. Successful early neonatal repair of cleft lip within first 8 days of life. Int J Pediatr Otorhinolaryngol. 2012 Nov;76(11):1616-26. doi: 10.1016/j.ijporl.2012.07.031. Epub 2012 Aug 18. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Comparison of the palatal growth in orofacial cleft patients Comparison of the growth of the palate in complete and incomplete cleft patients 1 year
Secondary Differences between cleft types Morphological differences between complete and incomplete cleft types 1 year
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