<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03839290</url>
  </required_header>
  <id_info>
    <org_study_id>656216</org_study_id>
    <nct_id>NCT03839290</nct_id>
  </id_info>
  <brief_title>Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty</brief_title>
  <official_title>Three-dimensional Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty: Classic and Geometric Morphometric Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Anthropology and Human Genetics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Otorhinolaryngology, 2nd Faculty of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Newborns with Intensive Care Unit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charles University, Czech Republic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early neonatal cheiloplasty is modified surgery protocol applied in the first week of&#xD;
      newborn's life used for treating orofacial cleft patients. This prospective study analyzes&#xD;
      the effects of early neonatal cheiloplasty on the growth and development of maxilla and&#xD;
      palate during the observed period of one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multidisciplinary treatment of patients with orofacial clefts begins immediately after birth.&#xD;
      The first surgical procedure is early neonatal cheiloplasty applied in the first week of the&#xD;
      newborn's life, which has been practiced in the Czech Republic for many years. It is a&#xD;
      popular parental choice and has a lot of benefits compared to classic cheiloplasty performed&#xD;
      between 3-6 months. Unrestricted growth of jaws is essential for the successful therapy of&#xD;
      aesthetics and functions. Although there are known a lot of benefits to this surgery, its&#xD;
      influence on facial growth is still being studied.&#xD;
&#xD;
      The methodology of this study is based on modern three-dimensional imaging methods and will&#xD;
      be evaluated by classic and geometric morphometric analysis of virtual dental models. The&#xD;
      existing database includes 137 virtual dental casts (complete and incomplete bilateral or&#xD;
      unilateral cleft lip and palate).&#xD;
&#xD;
      The main aim is to verify that the effects of early neonatal cheiloplasty on the facial or&#xD;
      palatal growth are minimal in affected individuals and therefore the subsequent development&#xD;
      of these structures can be predicted at a later age. Other goals are to evaluate palatal&#xD;
      morphology before and one year after early neonatal cheiloplasty, to assess growth of maxilla&#xD;
      and palate using classic and geometric morphometry, to assess morphological differences&#xD;
      between cleft types and to compare the results with previously published data of neonates&#xD;
      operated by later operation protocol and noncleft control groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Growth changes during the first year of life</measure>
    <time_frame>T0 before early neonatal cheiloplasty (5 ± 5 days) and T1 before palatoplasty (12 ± 6 months).</time_frame>
    <description>Analysis of palatal growth changes in individuals with orofacial clefts after neonatal cheiloplasty (5 ± 5 days) and before palatoplasty (12 ± 6 months).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of the palatal growth in orofacial cleft patients</measure>
    <time_frame>1 year</time_frame>
    <description>Comparison of the growth of the palate in complete and incomplete cleft patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between cleft types</measure>
    <time_frame>1 year</time_frame>
    <description>Morphological differences between complete and incomplete cleft types</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">137</enrollment>
  <condition>Cleft Palate</condition>
  <condition>Cleft Lip</condition>
  <condition>Cleft Lip and Palate</condition>
  <condition>Cleft Lip, Bilateral</condition>
  <arm_group>
    <arm_group_label>Bilateral cleft lip and palate patients</arm_group_label>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unilateral cleft lip and palate patients</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Early neonatal cheiloplasty</intervention_name>
    <arm_group_label>Bilateral cleft lip and palate patients</arm_group_label>
    <arm_group_label>Unilateral cleft lip and palate patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Newborns with orofacial clefts operated in the first week of life at the Motol University&#xD;
        Hospital in Prague by the same surgeon following the modified Veau surgery protocol.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nonsyndromic orofacial cleft&#xD;
&#xD;
          -  Czech origin&#xD;
&#xD;
          -  Operated by the same surgeon&#xD;
&#xD;
          -  Following same surgery protocol (modified Veau surgery protocol)&#xD;
&#xD;
          -  Excellent body temperature, blood pressure, oxygen saturation, heart function&#xD;
&#xD;
          -  Performing of early neonatal cheiloplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor health&#xD;
&#xD;
          -  Syndromic orofacial cleft&#xD;
&#xD;
          -  Operated by later operation protocol (3-6 months)&#xD;
&#xD;
          -  Non-Czech origin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jana Velemínská</last_name>
    <role>Study Director</role>
    <affiliation>Department of Anthropology and Human Genetics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jiří Borský</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Otorhinolaryngology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lenka Jaklová</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anthropology and Human Genetics</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lenka Jaklová</last_name>
    <phone>723899485</phone>
    <email>jaklovale@natur.cuni.cz</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lenka Jaklová</name>
      <address>
        <city>Praha</city>
        <state>Czech Republic</state>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lenka Jaklová</last_name>
      <phone>723899485</phone>
      <email>jaklovale@natur.cuni.cz</email>
    </contact>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <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>
    <PMID>29728158</PMID>
  </reference>
  <reference>
    <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>
    <PMID>27729158</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22906307</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charles University, Czech Republic</investigator_affiliation>
    <investigator_full_name>Jana Velemínská</investigator_full_name>
    <investigator_title>Head of the Department of Anthropology and Human Genetics, Head of Laboratory of 3D Imaging and Analytical Methods</investigator_title>
  </responsible_party>
  <keyword>bilateral cleft lip and palate</keyword>
  <keyword>unilateral cleft lip and palate</keyword>
  <keyword>3D geometric morphometrics</keyword>
  <keyword>upper dental arch</keyword>
  <keyword>classical morphometrics</keyword>
  <keyword>early neonatal cheiloplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cleft Palate</mesh_term>
    <mesh_term>Cleft Lip</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03839290
org study id: 656216
nct id: NCT03839290
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
measure: Growth changes during the first year of life
time frame: T0 before early neonatal cheiloplasty (5 ± 5 days) and T1 before palatoplasty (12 ± 6 months).
description: Analysis of palatal growth changes in individuals with orofacial clefts after neonatal cheiloplasty (5 ± 5 days) and before palatoplasty (12 ± 6 months).
measure: Comparison of the palatal growth in orofacial cleft patients
time frame: 1 year
description: Comparison of the growth of the palate in complete and incomplete cleft patients
measure: Differences between cleft types
time frame: 1 year
description: Morphological differences between complete and incomplete cleft types
arm group label: Bilateral cleft lip and palate patients
description: 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
arm group label: Unilateral cleft lip and palate patients
description: 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
intervention type: Procedure
intervention name: Early neonatal cheiloplasty
arm group label: Bilateral cleft lip and palate patients
arm group label: Unilateral cleft lip and palate patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Year
healthy volunteers: No
last name: Jana Velemínská
role: Study Director
affiliation: Department of Anthropology and Human Genetics
last name: Jiří Borský
role: Study Chair
affiliation: Department of Otorhinolaryngology
last name: Lenka Jaklová
role: Study Chair
affiliation: Department of Anthropology and Human Genetics
last name: Lenka Jaklová
phone: 723899485
email: jaklovale@natur.cuni.cz
facility: 
status: Recruiting
contact: 
country: Czechia
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.
PMID: 29728158
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.
PMID: 27729158
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.
PMID: 22906307
responsible party type: Principal Investigator
investigator affiliation: Charles University, Czech Republic
investigator full name: Jana Velemínská
investigator title: Head of the Department of Anthropology and Human Genetics, Head of Laboratory of 3D Imaging and Analytical Methods
mesh term: Cleft Palate
mesh term: Cleft Lip
sharing ipd: No