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

NCT ID: NCT03839290

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 137 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-05-31

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.

Conditions

Cleft Palate; Cleft Lip; Cleft Lip and Palate; Cleft Lip, Bilateral

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Early neonatal cheiloplasty

Intervention Type: PROCEDURE

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

Early neonatal cheiloplasty

Intervention Type: PROCEDURE

Interventions

Early neonatal cheiloplasty

Intervention Type: PROCEDURE

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

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anthropology and Human Genetics

UNKNOWN

Sponsor Role: collaborator

Otorhinolaryngology, 2nd Faculty of Medicine

UNKNOWN

Sponsor Role: collaborator

Department of Newborns with Intensive Care Unit

UNKNOWN

Sponsor Role: collaborator

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Jana Velemínská

Head of the Department of Anthropology and Human Genetics, Head of Laboratory of 3D Imaging and Analytical Methods

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jana Velemínská

Role: STUDY_DIRECTOR

Department of Anthropology and Human Genetics

Jiří Borský

Role: STUDY_CHAIR

Department of Otorhinolaryngology

Lenka Jaklová

Role: STUDY_CHAIR

Department of Anthropology and Human Genetics

Locations

Lenka Jaklová

Prague, Czech Republic, Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Lenka Jaklová

Role: CONTACT

jaklovale@natur.cuni.cz

723899485

Facility Contacts

Lenka Jaklová

Role: primary

jaklovale@natur.cuni.cz

723899485

References

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.

Reference Type: BACKGROUND

PMID: 29728158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27729158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22906307 (View on PubMed)

Other Identifiers

656216

Identifier Type: -

Identifier Source: org_study_id