- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02702869
Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet) (ACCQUIREnet)
Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet): Prospective Data-collection System and Learning Health-care Network for the Comprehensive Appraisal of Cleft and Craniofacial Care
Study Overview
Status
Conditions
Intervention / Treatment
- Procedure: cleft lip repair
- Procedure: gingivoperiosteoplasty
- Procedure: LeFort-1 maxillary repositioning
- Procedure: rhinoplasty
- Other: speech therapy
- Procedure: orthodontia
- Procedure: presurgical orthopedics
- Procedure: cleft palate repair
- Procedure: oronasal fistula repair
- Procedure: pharyngoplasty
- Procedure: myringotomy and tympanostomy tube placement
- Device: sound amplification for hearing
Detailed Description
The purpose of this project is to implement a system of prospective, standardized data collection for all patients with cleft lip and/or palate (CL/P) treated by the cleft and craniofacial centers that participate in ACCQUIREnet.
Adoption of this prospective data-collection system has two principal goals:
- To enable on-demand and scheduled review of cleft-care-related safety and outcomes data and team performance for the purpose of internal audits and continuous quality improvement; and
- To permit participation in multi-site, collaborative quality-improvement projects and/or research networks that require usage of these standardized data-collection methods. (These collaborations are described in corresponding IRB protocols and data-transfer agreements. Patient privacy and confidentiality is protected at all times.)
All patients with CL/P treated at cleft and craniofacial centers participating in ACCQUIREnet will be invited to participate in this project. Duke University serves as the coordinating center and statistical support center for the study. Data are maintained in a local, secured database.
The IRB protocol details methods of quality assurance, data monitoring, and auditing. Data dictionaries employed in ACCQUIREnet include the CleftCap REDCap project template, CleftKit Common Data Model (an extension of the PCORnet Common Data Model), the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, and the CLEFT-Q patient-reported outcome manual, maintained by the International Consortium for Health Outcomes Measurement (ichom.org) and McMaster University, respectively.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- Dalhousie University - IWK Health Centre
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Florida
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Gainesville, Florida, United States, 32608
- University of Florida - Shands Hospital
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Hollywood, Florida, United States, 33021
- Joe DiMaggio Children's Hospital
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Orlando, Florida, United States, 32806
- Orlando Health - Arnold Palmer Hospital for Children
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Saint Petersburg, Florida, United States, 33701
- Johns Hopkins - All Children's Hospital (JHACH)
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Maine
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Portland, Maine, United States, 04102
- Maine Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Harvard University - Boston Children's Hospital (BCH)
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University - St. Louis Children's Hospital (WUSTL)
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University - Duke Children's Hospital & Health Center
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University - Brenner Children's Hospital
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Texas
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Houston, Texas, United States, 77030
- University of Texas at Houston - Children's Memorial Hermann Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Typical orofacial clefts, of which subtypes are:
- Unilateral or bilateral cleft lip
- Unilateral or bilateral cleft lip and alveolus
- Unilateral or bilateral cleft lip and alveolus and palate
- Unilateral or bilateral cleft lip and palate
- Overt cleft palate
- Occult cleft palate
Exclusion Criteria:
- Atypical (Tessier) facial clefts
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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uCL(A)
Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate.
Subgroup analysis by severity of lip (complete, incomplete, or lesser-form).
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Other Names:
Other Names:
Other Names:
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uCL(A)P
Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate.
Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III).
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Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
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bCL(A)
Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate.
Subgroup analysis by severity of lip (complete, incomplete, or lesser-form).
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Other Names:
Other Names:
Other Names:
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bCL(A)P
Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate.
Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV).
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Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
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CP
Children with cleft secondary palate only, but intact lip and alveolus.
Subgroup analysis by severity (submucous, Veau-I, or Veau-II).
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Other Names:
Other Names:
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech: intelligibility
Time Frame: ~5 years of age
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Utilizes the intelligibility in context scale (ICS)
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~5 years of age
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Speech: intelligibility
Time Frame: ~8 years of age
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Utilizes the intelligibility in context scale (ICS)
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~8 years of age
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Speech: intelligibility
Time Frame: ~12 years of age
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Utilizes the intelligibility in context scale (ICS)
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~12 years of age
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Speech: intelligibility
Time Frame: ~22 years of age
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Utilizes the intelligibility in context scale (ICS)
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~22 years of age
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Speech: velopharyngeal competence
Time Frame: ~5 years of age
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~5 years of age
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Speech: velopharyngeal competence
Time Frame: ~8 years of age
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~8 years of age
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Speech: velopharyngeal competence
Time Frame: ~12 years of age
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~12 years of age
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Speech: velopharyngeal competence
Time Frame: ~22 years of age
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~22 years of age
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Speech: articulation
Time Frame: ~5 years of age
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Utilizes the modified percent correct consonants (mPCC) scale
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~5 years of age
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Speech: articulation
Time Frame: ~8 years of age
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Utilizes the modified percent correct consonants (mPCC) scale
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~8 years of age
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Speech: articulation
Time Frame: ~12 years of age
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Utilizes the modified percent correct consonants (mPCC) scale
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~12 years of age
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Speech: articulation
Time Frame: ~22 years of age
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Utilizes the modified percent correct consonants (mPCC) scale
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~22 years of age
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Speech: patient-reported outcomes related to speech and speaking
Time Frame: ~8 years of age
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Utilizes the CLEFT-Q PROM
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~8 years of age
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Speech: patient-reported outcomes related to speech and speaking
Time Frame: ~12 years of age
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Utilizes the CLEFT-Q PROM
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~12 years of age
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Speech: patient-reported outcomes related to speech and speaking
Time Frame: ~22 years of age
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Utilizes the CLEFT-Q PROM
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~22 years of age
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Hearing: puretone average
Time Frame: ~5 years of age
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~5 years of age
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Dental: dmft and DMFT scores
Time Frame: ~5 years of age
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Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
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~5 years of age
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Dental: dmft and DMFT scores
Time Frame: ~12 years of age
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Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
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~12 years of age
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Dental: dmft and DMFT scores
Time Frame: ~22 years of age
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Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
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~22 years of age
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Dental: occlusion (Uses modifications of the GOSLON scale)
Time Frame: ~5 years of age
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~5 years of age
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Dental: occlusion (Uses modifications of the Bauru scale)
Time Frame: ~5 years of age
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~5 years of age
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Dental: occlusion (Uses modifications of the GOSLON scale)
Time Frame: ~12 years of age
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~12 years of age
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Dental: occlusion (Uses modifications of the Bauru scale)
Time Frame: ~12 years of age
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~12 years of age
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Dental: occlusion (Uses modifications of the GOSLON scale)
Time Frame: ~22 years of age
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~22 years of age
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Dental: occlusion (Uses modifications of the Bauru scale)
Time Frame: ~22 years of age
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~22 years of age
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Dental: patient-reported outcomes related to mastication
Time Frame: ~8 years of age
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Uses the CLEFT-Q PROM
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~8 years of age
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Dental: patient-reported outcomes related to mastication
Time Frame: ~12 years of age
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Uses the CLEFT-Q PROM
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~12 years of age
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Dental: patient-reported outcomes related to mastication
Time Frame: ~22 years of age
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Uses the CLEFT-Q PROM
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~22 years of age
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Dental: patient-reported outcomes related to oral health
Time Frame: ~8 years of age
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Uses the COHIP PROM
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~8 years of age
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Dental: patient-reported outcomes related to oral health
Time Frame: ~12 years of age
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Uses the COHIP PROM
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~12 years of age
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Dental: patient-reported outcomes related to oral health
Time Frame: ~22 years of age
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Uses the COHIP PROM
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~22 years of age
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Patient-reported outcomes related to eating/drinking
Time Frame: ~8 years of age
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Uses the CLEFT-Q PROM
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~8 years of age
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Patient-reported outcomes related to eating/drinking
Time Frame: ~12 years of age
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Uses the CLEFT-Q PROM
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~12 years of age
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Patient-reported outcomes related to eating/drinking
Time Frame: ~22 years of age
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Uses the CLEFT-Q PROM
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~22 years of age
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Breathing: Patient-reported outcomes related to nasal and oral breathing
Time Frame: ~8 years of age
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Uses the NOSE PROM
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~8 years of age
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Breathing: Patient-reported outcomes related to nasal and oral breathing
Time Frame: ~12 years of age
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Uses the NOSE PROM
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~12 years of age
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Breathing: Patient-reported outcomes related to nasal and oral breathing
Time Frame: ~22 years of age
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Uses the NOSE PROM
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~22 years of age
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Aesthetics: Patient-reported outcomes related to appearance
Time Frame: ~8 years of age
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Uses the CLEFT-Q PROM
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~8 years of age
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Aesthetics: Patient-reported outcomes related to appearance
Time Frame: ~12 years of age
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Uses the CLEFT-Q PROM
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~12 years of age
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Aesthetics: Patient-reported outcomes related to appearance
Time Frame: ~22 years of age
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Uses the CLEFT-Q PROM
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~22 years of age
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Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time Frame: ~2 years of age
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~2 years of age
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Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time Frame: ~5 years of age
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~5 years of age
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Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time Frame: ~8 years of age
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~8 years of age
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Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time Frame: ~12 years of age
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~12 years of age
|
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Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time Frame: ~22 years of age
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~22 years of age
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexander C Allori, MD, MPH, Duke University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00104806
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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