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

February 25, 2019 updated by: Jana Velemínská, Charles University, Czech Republic

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Czech Republic
      • Praha, Czech Republic, Czechia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bilateral cleft lip and palate patients
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
Unilateral cleft lip and palate patients
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
Time Frame: 1 year
Comparison of the growth of the palate in complete and incomplete cleft patients
1 year
Differences between cleft types
Time Frame: 1 year
Morphological differences between complete and incomplete cleft types
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Collaborators

Anthropology and Human Genetics
Otorhinolaryngology, 2nd Faculty of Medicine
Department of Newborns with Intensive Care Unit

Investigators

  • Study Director: Jana Velemínská, Department of Anthropology and Human Genetics
  • Study Chair: Jiří Borský, Department of Otorhinolaryngology
  • Study Chair: Lenka Jaklová, Department of Anthropology and Human Genetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 11, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 656216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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