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

NCT03839290 | Unknown

• 1 other identifier: 656216
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  1 year

• Differences between cleft types

  1 year

Study Arms (2)

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

Interventions

Early neonatal cheiloplasty PROCEDURE

Bilateral cleft lip and palate patients; Unilateral cleft lip and palate patients

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Poor health
• Syndromic orofacial cleft
• Operated by later operation protocol (3-6 months)
• Non-Czech origin

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Anthropology and Human Genetics: collaborator
• Otorhinolaryngology, 2nd Faculty of Medicine: collaborator
• Department of Newborns with Intensive Care Unit: collaborator

Study Sites (1)

Lenka Jaklová

Prague, Czech Republic, Czechia

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cleft Palate; Cleft Lip

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lip Diseases

Study Officials

• Jana Velemínská

  Department of Anthropology and Human Genetics

  STUDY DIRECTOR

• Jiří Borský

  Department of Otorhinolaryngology

  STUDY CHAIR

• Lenka Jaklová

  Department of Anthropology and Human Genetics

  STUDY CHAIR

Central Study Contacts

Lenka Jaklová

CONTACT

723899485; jaklovale@natur.cuni.cz

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anthropology and Human Genetics, Head of Laboratory of 3D Imaging and Analytical Methods

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: September 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)