An observational study in Cleft Lip, Cleft Palate and Cleft Lip and Palate, sponsored by Duke University. Enrolling by invitation at 11 sites in 2 countries. Open to participants aged 1 Day to 22 Years. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Duke University · Observational
The Allied Cleft \& Craniofacial Quality-Improvement and Research Network (ACCQUIREnet) is a group of multidisciplinary cleft teams that have implemented a system for prospective collection of outcomes data, based on the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, CLEFT-Q, and other outcomes instruments. Participating cleft teams may analyze clinical and psychosocial outcomes related to care of the child with cleft lip and/or palate (CL/P), compare its performance with those of other cleft centers, and identify opportunities for quality improvement.
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:
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.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 100 across 49 observational studies indexed under Cleft Lip.
Browse Cleft Lip studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients born with cleft lip and/or palate are eligible for inclusion in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form).
Procedure: cleft lip repair · Procedure: gingivoperiosteoplasty · Procedure: LeFort-1 maxillary repositioning · Procedure: rhinoplasty · Other: speech therapy · Procedure: orthodontia · Procedure: presurgical orthopedics
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).
Procedure: cleft lip repair · Procedure: cleft palate repair · Procedure: oronasal fistula repair · Procedure: pharyngoplasty · Procedure: gingivoperiosteoplasty · Procedure: LeFort-1 maxillary repositioning · Procedure: rhinoplasty · Procedure: myringotomy and tympanostomy tube placement · Other: speech therapy · Procedure: orthodontia · Procedure: presurgical orthopedics · Device: sound amplification for hearing
Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form).
Procedure: cleft lip repair · Procedure: gingivoperiosteoplasty · Procedure: LeFort-1 maxillary repositioning · Procedure: rhinoplasty · Other: speech therapy · Procedure: orthodontia · Procedure: presurgical orthopedics
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).
Procedure: cleft lip repair · Procedure: cleft palate repair · Procedure: oronasal fistula repair · Procedure: pharyngoplasty · Procedure: gingivoperiosteoplasty · Procedure: LeFort-1 maxillary repositioning · Procedure: rhinoplasty · Procedure: myringotomy and tympanostomy tube placement · Other: speech therapy · Procedure: orthodontia · Procedure: presurgical orthopedics · Device: sound amplification for hearing
Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II).
Procedure: cleft palate repair · Procedure: oronasal fistula repair · Procedure: pharyngoplasty · Procedure: LeFort-1 maxillary repositioning · Procedure: myringotomy and tympanostomy tube placement · Other: speech therapy · Device: sound amplification for hearing
Also known as: cheiloplasty
Also known as: palatoplasty
Also known as: sphincteroplasty
Also known as: orthognathic surgery
Also known as: nasoalveolar molding, dentofacial orthopedics, Georgiade-Latham appliance, Latham appliance
Also known as: hearing aid
Speech: intelligibility
Utilizes the intelligibility in context scale (ICS)
Time frame: ~5 years of age
Speech: intelligibility
Utilizes the intelligibility in context scale (ICS)
Time frame: ~8 years of age
Speech: intelligibility
Utilizes the intelligibility in context scale (ICS)
Time frame: ~12 years of age
Speech: intelligibility
Utilizes the intelligibility in context scale (ICS)
Time frame: ~22 years of age
Speech: velopharyngeal competence
Time frame: ~5 years of age
Speech: velopharyngeal competence
Time frame: ~8 years of age
Speech: velopharyngeal competence
Time frame: ~12 years of age
Speech: velopharyngeal competence
Time frame: ~22 years of age
Speech: articulation
Utilizes the modified percent correct consonants (mPCC) scale
Time frame: ~5 years of age
Speech: articulation
Utilizes the modified percent correct consonants (mPCC) scale
Time frame: ~8 years of age
Speech: articulation
Utilizes the modified percent correct consonants (mPCC) scale
Time frame: ~12 years of age
Speech: articulation
Utilizes the modified percent correct consonants (mPCC) scale
Time frame: ~22 years of age
Speech: patient-reported outcomes related to speech and speaking
Utilizes the CLEFT-Q PROM
Time frame: ~8 years of age
Speech: patient-reported outcomes related to speech and speaking
Utilizes the CLEFT-Q PROM
Time frame: ~12 years of age
Speech: patient-reported outcomes related to speech and speaking
Utilizes the CLEFT-Q PROM
Time frame: ~22 years of age
Hearing: puretone average
Time frame: ~5 years of age
Dental: dmft and DMFT scores
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Time frame: ~5 years of age
Dental: dmft and DMFT scores
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Time frame: ~12 years of age
Dental: dmft and DMFT scores
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Time frame: ~22 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)
Time frame: ~5 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
Time frame: ~5 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)
Time frame: ~12 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
Time frame: ~12 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)
Time frame: ~22 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
Time frame: ~22 years of age
Dental: patient-reported outcomes related to mastication
Uses the CLEFT-Q PROM
Time frame: ~8 years of age
Dental: patient-reported outcomes related to mastication
Uses the CLEFT-Q PROM
Time frame: ~12 years of age
Dental: patient-reported outcomes related to mastication
Uses the CLEFT-Q PROM
Time frame: ~22 years of age
Dental: patient-reported outcomes related to oral health
Uses the COHIP PROM
Time frame: ~8 years of age
Dental: patient-reported outcomes related to oral health
Uses the COHIP PROM
Time frame: ~12 years of age
Dental: patient-reported outcomes related to oral health
Uses the COHIP PROM
Time frame: ~22 years of age
Patient-reported outcomes related to eating/drinking
Uses the CLEFT-Q PROM
Time frame: ~8 years of age
Patient-reported outcomes related to eating/drinking
Uses the CLEFT-Q PROM
Time frame: ~12 years of age
Patient-reported outcomes related to eating/drinking
Uses the CLEFT-Q PROM
Time frame: ~22 years of age
Breathing: Patient-reported outcomes related to nasal and oral breathing
Uses the NOSE PROM
Time frame: ~8 years of age
Breathing: Patient-reported outcomes related to nasal and oral breathing
Uses the NOSE PROM
Time frame: ~12 years of age
Breathing: Patient-reported outcomes related to nasal and oral breathing
Uses the NOSE PROM
Time frame: ~22 years of age
Aesthetics: Patient-reported outcomes related to appearance
Uses the CLEFT-Q PROM
Time frame: ~8 years of age
Aesthetics: Patient-reported outcomes related to appearance
Uses the CLEFT-Q PROM
Time frame: ~12 years of age
Aesthetics: Patient-reported outcomes related to appearance
Uses the CLEFT-Q PROM
Time frame: ~22 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~2 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~5 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~8 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~12 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~22 years of age
Plan to share: No — This is a collaborative research network. All data processing happens at the coordinating center, with results reviewed by the participating centers.
Started Oct 2016 (actual). Primary completion is estimated for Dec 2031, 182 months after the start.
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