# A comparative effectiveness study of speech and surgical treatments using a Cleft Palate Registry/Research Outcomes Network.

> **NIH NIH R01** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2021 · $1,190,574

## Abstract

PROJECT SUMMARY
 Over their lifetimes, children with cleft palate + lip (CP+L) undergo numerous surgical, orthodontic, and
behavioral interventions designed to lessen the impact of clefting. There is genuine uncertainty within the
expert medical community about the preferred surgical approaches to cleft palate repair. As a result, treatment
decisions are based on treating biases from prior training, clinical experiences, or provider expertise.
 The proposed project intends to compare the two most common cleft palate repair techniques, straight-
line closure with intra-velar veloplasty (IVVP) and Furlow Z-plasty palatal lengthening, to determine their effect
on speech outcome and on the subsequent development of fistulas, a common adverse event following
surgical repair of the palate. Instead of efficacy, the study of interventions in a select population under ideal
conditions, the target of the proposed study is effectiveness, the comparison of these techniques in real-world
clinical settings and across the full continuum of severity and comorbidity seen in clinical care – data that are
sorely needed to inform medical decision making for CP+L. In addition, we will collect detailed information on
post-operative and follow-up care as well as speech-language therapy practices to illuminate the full horizon of
early care practices for CP+L. To achieve this real-world data capture, we will establish a multi-institutional,
point-of-care data capture system that harmonizes the practice data from leading cleft care programs across
North America.
 The completion of this proposed project will advance knowledge about surgical approaches to CP+L as
well as subsequent inpatient and outpatient care. The authentic and detailed care information about how
different individuals respond to surgical interventions would help providers deliver the right care at the right
time to the right patient. Better characterization of therapy interventions would inform the development of care
pathways for outpatient CP+L care that have the potential to realize more informed, effective and equitable
care. Finally, in addition to the direct impact on care that can be realized by the hypothesis testing proposed
herein, the establishment of a point-of-care data capture clinical research registry for CP+L holds the potential
to be an enduring contribution to the field and to support conduction of timely and clinically relevant research
for years to come.

## Key facts

- **NIH application ID:** 10116985
- **Project number:** 5R01DE027493-04
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** KATHY L CHAPMAN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,190,574
- **Award type:** 5
- **Project period:** 2018-03-01 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10116985

## Citation

> US National Institutes of Health, RePORTER application 10116985, A comparative effectiveness study of speech and surgical treatments using a Cleft Palate Registry/Research Outcomes Network. (5R01DE027493-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10116985. Licensed CC0.

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