Status:
UNKNOWN
Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty
Lead Sponsor:
Charles University, Czech Republic
Collaborating Sponsors:
Anthropology and Human Genetics
Otorhinolaryngology, 2nd Faculty of Medicine
Conditions:
Cleft Palate
Cleft Lip
Eligibility:
All Genders
Up to 1 years
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 ne...
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 lif...
Eligibility Criteria
Inclusion
- 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
- Poor health
- Syndromic orofacial cleft
- Operated by later operation protocol (3-6 months)
- Non-Czech origin
Key Trial Info
Start Date :
September 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2019
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT03839290
Start Date
September 1 2016
End Date
May 1 2019
Last Update
February 26 2019
Active Locations (1)
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1
Lenka Jaklová
Prague, Czech Republic, Czechia