Clinical trial NCT03839290: Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty
Official title: Three-dimensional Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty: Classic and Geometric Morphometric Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cleft Palate
Cleft Lip
Cleft Lip and Palate
Cleft Lip, Bilateral
Keywords: bilateral cleft lip and palate
unilateral cleft lip and palate
3D geometric morphometrics
upper dental arch
classical morphometrics
early neonatal cheiloplasty
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Anthropology and Human Genetics
name: Otorhinolaryngology, 2nd Faculty of Medicine
name: Department of Newborns with Intensive Care Unit
First posted: 2019-02-15
Enrollment: 137
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns with orofacial clefts operated in the first week of life at the Motol University Hospital in Prague by the same surgeon following the modified Veau surgery protocol.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Growth changes during the first year of life
timeFrame: T0 before early neonatal cheiloplasty (5 ± 5 days) and T1 before palatoplasty (12 ± 6 months).
Secondary outcomes:
measure: Comparison of the palatal growth in orofacial cleft patients
timeFrame: 1 year
measure: Differences between cleft types
timeFrame: 1 year
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Lenka Jaklová
state: Czech Republic
Study officials:
affiliation: Department of Anthropology and Human Genetics
name: Jana Velemínská
role: STUDY_DIRECTOR
affiliation: Department of Otorhinolaryngology
name: Jiří Borský
role: STUDY_CHAIR
affiliation: Department of Anthropology and Human Genetics
name: Lenka Jaklová
role: STUDY_CHAIR
References:
citation: Hoffmannova E, Moslerova V, Dupej J, Borsky J, Bejdova S, Veleminska 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.
citation: Hoffmannova E, Bejdova S, Borsky J, Dupej J, Caganova V, Veleminska 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.
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.