Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)

NCT02702869 | Enrolling By Invitation DMC

• 1 other identifier: Pro00104806
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 11

Brief Summary

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.

Conditions

Cleft Lip; Cleft Palate; Cleft Lip and Palate

Keywords

cleft lip; cleft palate; cleft lip and palate; cleft alveolus; multidisciplinary team; interdisciplinary team

Outcome Measures

Primary Outcomes (45)

• Speech: intelligibility

  Utilizes the intelligibility in context scale (ICS)

  ~5 years of age

• Speech: intelligibility

  Utilizes the intelligibility in context scale (ICS)

  ~8 years of age

• Speech: intelligibility

  Utilizes the intelligibility in context scale (ICS)

  ~12 years of age

• Speech: intelligibility

  Utilizes the intelligibility in context scale (ICS)

  ~22 years of age

• Speech: velopharyngeal competence

  ~5 years of age

• Speech: velopharyngeal competence

  ~8 years of age

• Speech: velopharyngeal competence

  ~12 years of age

• Speech: velopharyngeal competence

  ~22 years of age

• Speech: articulation

  Utilizes the modified percent correct consonants (mPCC) scale

  ~5 years of age

• Speech: articulation

  Utilizes the modified percent correct consonants (mPCC) scale

  ~8 years of age

• Speech: articulation

  Utilizes the modified percent correct consonants (mPCC) scale

  ~12 years of age

• Speech: articulation

  Utilizes the modified percent correct consonants (mPCC) scale

  ~22 years of age

• Speech: patient-reported outcomes related to speech and speaking

  Utilizes the CLEFT-Q PROM

  ~8 years of age

• Speech: patient-reported outcomes related to speech and speaking

  Utilizes the CLEFT-Q PROM

  ~12 years of age

• Speech: patient-reported outcomes related to speech and speaking

  Utilizes the CLEFT-Q PROM

  ~22 years of age

• Hearing: puretone average

  ~5 years of age

• Dental: dmft and DMFT scores

  Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth

  ~5 years of age

• Dental: dmft and DMFT scores

  Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth

  ~12 years of age

• Dental: dmft and DMFT scores

  Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth

  ~22 years of age

• Dental: occlusion (Uses modifications of the GOSLON scale)

  ~5 years of age

• Dental: occlusion (Uses modifications of the Bauru scale)

  ~5 years of age

• Dental: occlusion (Uses modifications of the GOSLON scale)

  ~12 years of age

• Dental: occlusion (Uses modifications of the Bauru scale)

  ~12 years of age

• Dental: occlusion (Uses modifications of the GOSLON scale)

  ~22 years of age

• Dental: occlusion (Uses modifications of the Bauru scale)

  ~22 years of age

• Dental: patient-reported outcomes related to mastication

  Uses the CLEFT-Q PROM

  ~8 years of age

• Dental: patient-reported outcomes related to mastication

  Uses the CLEFT-Q PROM

  ~12 years of age

• Dental: patient-reported outcomes related to mastication

  Uses the CLEFT-Q PROM

  ~22 years of age

• Dental: patient-reported outcomes related to oral health

  Uses the COHIP PROM

  ~8 years of age

• Dental: patient-reported outcomes related to oral health

  Uses the COHIP PROM

  ~12 years of age

• Dental: patient-reported outcomes related to oral health

  Uses the COHIP PROM

  ~22 years of age

• Patient-reported outcomes related to eating/drinking

  Uses the CLEFT-Q PROM

  ~8 years of age

• Patient-reported outcomes related to eating/drinking

  Uses the CLEFT-Q PROM

  ~12 years of age

• Patient-reported outcomes related to eating/drinking

  Uses the CLEFT-Q PROM

  ~22 years of age

• Breathing: Patient-reported outcomes related to nasal and oral breathing

  Uses the NOSE PROM

  ~8 years of age

• Breathing: Patient-reported outcomes related to nasal and oral breathing

  Uses the NOSE PROM

  ~12 years of age

• Breathing: Patient-reported outcomes related to nasal and oral breathing

  Uses the NOSE PROM

  ~22 years of age

• Aesthetics: Patient-reported outcomes related to appearance

  Uses the CLEFT-Q PROM

  ~8 years of age

• Aesthetics: Patient-reported outcomes related to appearance

  Uses the CLEFT-Q PROM

  ~12 years of age

• Aesthetics: Patient-reported outcomes related to appearance

  Uses the CLEFT-Q PROM

  ~22 years of age

• Aesthetics: Clinical assessment of nasolabial and facial aesthetics

  ~2 years of age

• Aesthetics: Clinical assessment of nasolabial and facial aesthetics

  ~5 years of age

• Aesthetics: Clinical assessment of nasolabial and facial aesthetics

  ~8 years of age

• Aesthetics: Clinical assessment of nasolabial and facial aesthetics

  ~12 years of age

• Aesthetics: Clinical assessment of nasolabial and facial aesthetics

  ~22 years of age

Study Arms (5)

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).

Procedure: cleft lip repair; Procedure: gingivoperiosteoplasty; Procedure: LeFort-1 maxillary repositioning; Procedure: rhinoplasty; Other: speech therapy; Procedure: orthodontia; Procedure: presurgical orthopedics

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).

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

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).

Procedure: cleft lip repair; Procedure: gingivoperiosteoplasty; Procedure: LeFort-1 maxillary repositioning; Procedure: rhinoplasty; Other: speech therapy; Procedure: orthodontia; Procedure: presurgical orthopedics

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).

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

CP

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

Interventions

cleft lip repair PROCEDURE

Also known as: cheiloplasty

bCL(A); bCL(A)P; uCL(A); uCL(A)P

cleft palate repair PROCEDURE

Also known as: palatoplasty

CP; bCL(A)P; uCL(A)P

oronasal fistula repair PROCEDURE

CP; bCL(A)P; uCL(A)P

pharyngoplasty PROCEDURE

Also known as: sphincteroplasty

CP; bCL(A)P; uCL(A)P

gingivoperiosteoplasty PROCEDURE

bCL(A); bCL(A)P; uCL(A); uCL(A)P

LeFort-1 maxillary repositioning PROCEDURE

Also known as: orthognathic surgery

CP; bCL(A); bCL(A)P; uCL(A); uCL(A)P

rhinoplasty PROCEDURE

bCL(A); bCL(A)P; uCL(A); uCL(A)P

myringotomy and tympanostomy tube placement PROCEDURE

CP; bCL(A)P; uCL(A)P

speech therapy OTHER

CP; bCL(A); bCL(A)P; uCL(A); uCL(A)P

orthodontia PROCEDURE

bCL(A); bCL(A)P; uCL(A); uCL(A)P

presurgical orthopedics PROCEDURE

Also known as: nasoalveolar molding, dentofacial orthopedics, Georgiade-Latham appliance, Latham appliance

bCL(A); bCL(A)P; uCL(A); uCL(A)P

sound amplification for hearing DEVICE

Also known as: hearing aid

CP; bCL(A)P; uCL(A)P

Eligibility Criteria

• Age: 1 Day - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients born with cleft lip and/or palate are eligible for inclusion in this study.

You may qualify if:

• 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

You may not qualify if:

• Atypical (Tessier) facial clefts

Sponsors & Collaborators

• Duke University: lead

Study Sites (11)

University of Florida - Shands Hospital

Gainesville, Florida, 32608, United States

Location

Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

Orlando Health - Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

Location

Johns Hopkins - All Children's Hospital (JHACH)

St. Petersburg, Florida, 33701, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Harvard University - Boston Children's Hospital (BCH)

Boston, Massachusetts, 02115, United States

Location

Washington University - St. Louis Children's Hospital (WUSTL)

St Louis, Missouri, 63110, United States

Location

Duke University - Duke Children's Hospital & Health Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University - Brenner Children's Hospital

Winston-Salem, North Carolina, 27157, United States

Location

University of Texas at Houston - Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Dalhousie University - IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Links

• Duke Cleft \& Craniofacial Center
• Official web site for ICHOM Standard Set for cleft lip and/or palate, upon which the Duke project is based
• ACCQUIREnet web site

MeSH Terms

Conditions

Cleft Lip; Cleft Palate

Interventions

Sphincterotomy, Transduodenal; Orthognathic Surgery; Rhinoplasty; Middle Ear Ventilation; Speech Therapy; Orthodontics; Nasoalveolar Molding; Audiometry; Hearing Aids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Sphincterotomy; Myotomy; Surgery, Oral; Dentistry; Cosmetic Techniques; Therapeutics; Nasal Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Plastic Surgery Procedures; Ostomy; Otologic Surgical Procedures; Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Preoperative Care; Perioperative Care; Health Services; Health Care Facilities Workforce and Services; Hearing Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis; Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Officials

• Alexander C Allori, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 22 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: March 9, 2016
• Study Start: October 1, 2016
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); CA (1)