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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Duke University
Study ID
NCT02702869
Status
Enrolling By Invitation

Conditions

  • Cleft Lip
  • Cleft Lip and Palate
  • Cleft Palate

Eligibility Criteria

Sex
ALL
Age
1 Day - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 — PROCEDURE
  • speech therapy — OTHER
  • orthodontia — PROCEDURE
  • presurgical orthopedics — PROCEDURE
  • sound amplification for hearing — DEVICE

Study Details

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.

Key Dates

Start date
Oct 31, 2016
Status verified
Jan 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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).
  • Arm: 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).
  • Arm: 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).
  • Arm: 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).
  • Arm: CP
    Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II).

Primary Outcome Measure

Speech: intelligibility [ Time Frame: ~5 years of age ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of Florida - Shands HospitalGainesvilleFlorida32608-
Joe DiMaggio Children's HospitalHollywoodFlorida33021-
Orlando Health - Arnold Palmer Hospital for ChildrenOrlandoFlorida32806-
Johns Hopkins - All Children's Hospital (JHACH)St. PetersburgFlorida33701-
Maine Medical CenterPortlandMaine04102-
Harvard University - Boston Children's Hospital (BCH)BostonMassachusetts02115-
Washington University - St. Louis Children's Hospital (WUSTL)St LouisMissouri63110-
Duke University - Duke Children's Hospital & Health CenterDurhamNorth Carolina27710-
Wake Forest University - Brenner Children's HospitalWinston-SalemNorth Carolina27157-
University of Texas at Houston - Children's Memorial Hermann HospitalHoustonTexas77030-

Find similar trials in Gainesville, FL

By research site
University of Florida - Shands Hospital· Gainesville, FLJoe DiMaggio Children's Hospital· Hollywood, FLOrlando Health - Arnold Palmer Hospital for Children· Orlando, FLJohns Hopkins - All Children's Hospital (JHACH)· St. Petersburg, FLMaine Medical Center· Portland, MEHarvard University - Boston Children's Hospital (BCH)· Boston, MA

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