Cleft PalateNCT03839290
Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty
An observational study of Cleft Palate and Cleft Lip, run by Charles University, Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Cleft Palate, Cleft Lip, Cleft Lip and Palate
- What is being tested?
- Early neonatal cheiloplasty
- Type of treatment
- Surgery or procedure
- How many people
- 137 participants
- Where
- 1 siteCzechia
- Study dates
- Sep 2016to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Poor health
- Syndromic orofacial cleft
- Operated by later operation protocol (3-6 months)
- Non-Czech origin
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Lenka Jaklová
Prague, Czech Republic
Lenka Jaklová, 723899485, jaklovale@natur.cuni.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Cleft Palate, Cleft Lip, Cleft Lip and Palate, Cleft Lip, Bilateral
- Being tested
- Early neonatal cheiloplasty
- Keywords
- bilateral cleft lip and palate, unilateral cleft lip and palate, 3D geometric morphometrics, upper dental arch, classical morphometrics, early neonatal cheiloplasty
- Medical subject headings
- Cleft Palate, Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early neonatal cheiloplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Early neonatal cheiloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: T0 before early neonatal cheiloplasty (5 ± 5 days) and T1 before palatoplasty (12 ± 6 months).
Secondary outcomes (2)
Comparison of the palatal growth in orofacial cleft patients
Comparison of the growth of the palate in complete and incomplete cleft patients
Measured: 1 year
Differences between cleft types
Morphological differences between complete and incomplete cleft types
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study startSep 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Anthropology and Human Genetics, Otorhinolaryngology, 2nd Faculty of Medicine, Department of Newborns with Intensive Care Unit
- Responsible party
- Principal investigator, Jana Velemínská, Charles University, Czech Republic
- Investigators
- Jana Velemínská, Study director, Department of Anthropology and Human GeneticsJiří Borský, Study chair, Department of OtorhinolaryngologyLenka Jaklová, Study chair, Department of Anthropology and Human Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839290
- Sponsor's protocol ID
- 656216
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29728158Hoffmannova 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.
PubMed 27729158Jiri 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.
PubMed 22906307
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty: Classic and Geometric Morphometric Evaluation
- ClinicalTrials.gov ID
- NCT03839290
- Acronym / sponsor ID
- 656216
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Anthropology and Human Genetics, Otorhinolaryngology, 2nd Faculty of Medicine, Department of Newborns with Intensive Care Unit
- Study start
- Sep 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral cleft lip and palate patients | – | Procedure: Early neonatal cheiloplastyNewborns 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 |
| Unilateral cleft lip and palate patients | – | Procedure: Early neonatal cheiloplastyNewborns 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 |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Poor health
- Syndromic orofacial cleft
- Operated by later operation protocol (3-6 months)
- Non-Czech origin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early neonatal cheiloplasty | Procedure or surgery | Bilateral cleft lip and palate patients, Unilateral cleft lip and palate patients |
Primary outcome
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).
2 secondary outcomes
Comparison of the palatal growth in orofacial cleft patients
Time frame: 1 year
Differences between cleft types
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Background: PubMed 29728158Hoffmannova 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.
- Background: PubMed 27729158Hoffmannova 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.
- Background: PubMed 22906307Jiri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jana Velemínská study director
Department of Anthropology and Human Genetics
Jiří Borský study chair
Department of Otorhinolaryngology
Lenka Jaklová study chair
Department of Anthropology and Human Genetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Palate and Cleft Lip, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lenka Jaklová (723899485, jaklovale@natur.cuni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03839290, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.