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Velopharyngeal insufficiency following cleft palate repair: a comparative effectiveness study of existing surgical procedures and identification of criteria to guide a personalized treatment approach

Award Number: U01DE029750
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Velopharyngeal insufficiency (VPI) occurs in up to 40% of patients following cleft palate repair and results in hypernasality and nasal air emission during speech, which substantially limits communication. VPI has traditionally been treated with pharyngoplasty, which is over 80% effective but leads to obstructive sleep apnea (OSA) in 15%–50% of patients. To avoid the risk of OSA, some surgeons have begun performing palate re-repair to treat VPI. Early experience suggests re-repair is 84% effective in resolving VPI and that it does not lead to OSA, although results vary substantially depending upon the criteria for patient selection. Given the potential of re-repair to reduce the risk of OSA, and the substantial limitations in our knowledge about its effectiveness, there is a critical need to compare the effectiveness of palate re-repair to pharyngoplasty and to determine which patients are most likely to benefit from each operation. This proposal addresses this need through three specific aims: (1) Compare the effectiveness of palate re-repair with that of pharyngoplasty for treating VPI. (2) Determine the anatomic abnormalities of the palate that predict resolution of hypernasality following palate re-repair and following pharyngoplasty. (3) Identify barriers and facilitators to implementing personalized VPI procedure selection. Aims 1 and 2 will be achieved by conducting an observational comparative-effectiveness study of palate re-repair versus pharyngoplasty in patients with VPI following their initial cleft palate repair. The study will enroll 528 participants over a 3-year period from 10 cleft centers, using propensity score matching to control for known factors or those suspected of influencing surgical procedure assignment and speech outcome after surgery. Aim 1 will compare the two procedures for the outcomes of hypernasality, nasal air emission, and OSA at 12 months after VPI surgery. An overall comparison of procedures will be performed, as will subgroup analyses for patients with specific exam and morphologic criteria. Aim 2 will be achieved by obtaining velopharyngeal MRI on participants prior to VPI surgery; MRI enables direct evaluation of the velar muscles and soft tissues responsible for VPI. Aim 2 will test whether the anatomic anomalies of velar muscle dehiscence, velar muscle malposition, and/or a short velum, as visualized on MRI, predict resolution of hypernasality following palate re-repair. Aim 3 will use implementation science methods to understand providers’ current approach to VPI procedure selection, identifying factors that may delay or encourage implementation of a personalized approach to VPI management built upon findings in Aims 1 and 2. Completion of these aims will provide the first direct comparison of palate re-repair to pharyngoplasty for the treatment of VPI, establish the morphologic and anatomic features that predict successful treatment with each procedure, and identify barriers and facilitators to implementing personalized VPI procedure selection. The proposed research will produce a significant positive impact for children with VPI after cleft palate repair by enabling surgeons to select the most effective, least harmful surgical procedure for each child.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $839,292 )
2024	2024	PHOENIX CHILDREN'S HOSPITAL, INC	1919 E THOMAS ROAD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	001	5	7/30/2024	NON-COMPETING CONTINUATION	$799,745
2024	2024	PHOENIX CHILDREN'S HOSPITAL, INC	1919 E THOMAS ROAD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	004	5	8/29/2024	NON-COMPETING CONTINUATION	$0
2024	2024	PHOENIX CHILDREN'S HOSPITAL, INC	1919 E THOMAS ROAD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	002	5	7/31/2024	SUPPLEMENT FOR EXPANSION	$39,547
2024	2023	PHOENIX CHILDREN'S HOSPITAL, INC	1919 E THOMAS ROAD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	000	4	1/11/2024	NON-COMPETING CONTINUATION	$0
2024	2021	PHOENIX CHILDREN'S HOSPITAL, INC	1919 E THOMAS ROAD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	003	2	8/15/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $839,292

Issue Date FY: 2023 ( Subtotal = $799,400 )
2023	2023	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	002	4	6/30/2023	SUPPLEMENT FOR EXPANSION	$39,547
2023	2023	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	001	4	6/29/2023	NON-COMPETING CONTINUATION	$874,346
2023	2021	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	000	2	6/7/2023	NON-COMPETING CONTINUATION	-$114,493
														Subtotal = $799,400

Issue Date FY: 2022 ( Subtotal = $981,691 )
2022	2022	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	001	3	6/30/2022	NON-COMPETING CONTINUATION	$867,198
2022	2022	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	002	3	9/15/2022	NON-COMPETING CONTINUATION	$0
2022	2021	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	000	2	2/23/2022	NON-COMPETING CONTINUATION	$0
2022	2021	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	003	2	9/27/2022	NON-COMPETING CONTINUATION	$114,493
														Subtotal = $981,691

Issue Date FY: 2021 ( Subtotal = $783,963 )
2021	2021	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	008	2	6/30/2021	NON-COMPETING CONTINUATION	$783,963
2021	2020	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	007	1	6/17/2021	NEW	$0
2021	2020	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	009	1	8/12/2021	NEW	$0
2021	2020	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	005	1	5/10/2021	NEW	$0
2021	2020	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	003	1	2/18/2021	NEW	$0
2021	2020	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	010	1	9/1/2021	NEW	$0
2021	2020	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	002	1	2/12/2021	NEW	$0
2021	2020	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	001	1	2/8/2021	NEW	$0
2021	2020	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	006	1	5/19/2021	NEW	$0
2021	2020	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	004	1	3/10/2021	NEW	$0
2021	2020	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	000	1	2/4/2021	NEW	$0
														Subtotal = $783,963

Issue Date FY: 2020 ( Subtotal = $842,190 )
2020	2020	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	000	1	6/18/2020	NEW	$818,352
2020	2020	PHOENIX CHILDREN'S HOSPITAL, INC.	1919 E THOMAS RD	PHOENIX	AZ	85016	MARICOPA	USA	Oral Diseases and Disorders Research	001	1	6/25/2020	NEW	$23,838
														Subtotal = $842,190

Grand Total All Awards = $4,246,536

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Velopharyngeal insufficiency following cleft palate repair: a comparative effectiveness study of existing surgical procedures and identification of criteria to guide a personalized treatment approach

Award Number: U01DE029750

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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