Tuesday, May 7, 2024 5/7/2024

TOPS (Timing of Primary Surgery for Cleft Palate) trial Follow-up

Award Number: U01DE018664
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By Issue Date FY or Funding FY:

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¿ DESCRIPTION (provided by applicant): Isolated cleft palate is the commonest craniofacial birth anomaly (e.g., 4.5 per 10,000 births in the US). It creates problems in feeding, speech, hearing, and dental development. Unsuccessful surgery may fail to resolve these problems and reduce the child's potential for social development and inclusion. There is an inadequate evidence base for selecting the optimal timing for surgery, but a possible case for undertaking surgery at 6 months, rather than the more usual timing of 12 months or later. Providing a functioning palate when speech skills begin to develop may lead to better speech outcomes. Our randomized control trial comparing surgery at 6 months or 12 months in infants with isolated non-syndromic cleft palate (funded by NIDCR grants 1U01DE018664 and 1U01DE018837) began recruitment in September 2010. By June 2015, a total of 650 infants will have been recruited across 23 cleft centres in the United Kingdom, Scandinavia and Brazil. From July 2015, over the remaining 5 years of the study, we will follow every child, obtain standardised records at age 12 months, 3 years and 5 years, and compare a variety of outcomes. The main outcome will be the quality of speech (resonance, nasal airflow) as assessed by blinded listeners. Secondary outcomes will include articulation, surgical complications, hearing, growth, and dentofacial development. If significant differences are demonstrated, it is possible that improved knowledge about optimal timing will improve speech quality, and in turn, the social integration of affected children, while reducing the burden of remedial care that they and their families must endure, and the associated medical costs. The findings will be applicable to any country where cleft surgery can be planned in advance.


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: 2023 ( Subtotal = $18 )
2023	2019	THE UNIVERSITY OF MANCHESTER	OXFORD ROAD	MANCHESTER				GBR	Oral Diseases and Disorders Research	001	10	3/22/2023	NON-COMPETING CONTINUATION	$0
2023	2019	THE UNIVERSITY OF MANCHESTER	OXFORD ROAD	MANCHESTER				GBR	Oral Diseases and Disorders Research	000	10	2/24/2023	NON-COMPETING CONTINUATION	$18
														Subtotal = $18

Issue Date FY: 2022 ( Subtotal = -$2,919,914 )
2022	2019	THE UNIVERSITY OF MANCHESTER	OXFORD ROAD	MANCHESTER				GBR	Oral Diseases and Disorders Research	001	10	11/22/2021	NON-COMPETING CONTINUATION	-$1,691,777
2022	2018	THE UNIVERSITY OF MANCHESTER	OXFORD ROAD	MANCHESTER				GBR	Oral Diseases and Disorders Research	000	9	11/22/2021	NON-COMPETING CONTINUATION	-$1,228,137
														Subtotal = -$2,919,914

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	UNIVERSITY OF MANCHESTER	OXFORD RD	MANCHESTER	LANCASHIRE			GBR	Oral Diseases and Disorders Research	000	10	2/17/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	UNIVERSITY OF MANCHESTER	OXFORD RD	MANCHESTER	LANCASHIRE	M13 9PL		GBR	Oral Diseases and Disorders Research	000	10	3/12/2020	NON-COMPETING CONTINUATION	$0
2020	2019	UNIVERSITY OF MANCHESTER	OXFORD RD	MANCHESTER	LANCASHIRE	M13 9PL		GBR	Oral Diseases and Disorders Research	001	10	4/1/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $1,691,777 )
2019	2019	UNIVERSITY OF MANCHESTER	OXFORD RD	MANCHESTER	LANCASHIRE	M13 9PL		GBR	Oral Diseases and Disorders Research	001	10	6/28/2019	NON-COMPETING CONTINUATION	$1,691,777
2019	2018	UNIVERSITY OF MANCHESTER	OXFORD RD	MANCHESTER	LANCASHIRE	M13 9PL		GBR	Oral Diseases and Disorders Research	000	9	4/1/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,691,777

Issue Date FY: 2018 ( Subtotal = $1,562,574 )
2018	2018	UNIVERSITY OF MANCHESTER	OXFORD RD	MANCHESTER	LANCASHIRE	M13 9PL		GBR	Oral Diseases and Disorders Research	000	9	6/26/2018	NON-COMPETING CONTINUATION	$1,562,574
														Subtotal = $1,562,574

Issue Date FY: 2017 ( Subtotal = $1,478,290 )
2017	2017	UNIVERSITY OF MANCHESTER	OXFORD RD	MANCHESTER	LANCASHIRE	M13 9PL		GBR	Oral Diseases and Disorders Research	002	8	6/22/2017	NON-COMPETING CONTINUATION	$1,478,290
2017	2015	UNIVERSITY OF MANCHESTER	OXFORD RD	MANCHESTER	LANCASHIRE	M13 9PL		GBR	Oral Diseases and Disorders Research	001	6	12/22/2016	COMPETING CONTINUATION	$191,646
2017	2012	UNIVERSITY OF MANCHESTER	OXFORD RD	MANCHESTER	LANCASHIRE	M13 9PL		GBR	Oral Diseases and Disorders Research	000	5	12/22/2016	NON-COMPETING CONTINUATION	-$191,646
														Subtotal = $1,478,290

Issue Date FY: 2016 ( Subtotal = $1,315,176 )
2016	2016	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	000	7	6/17/2016	NON-COMPETING CONTINUATION	$1,315,176
														Subtotal = $1,315,176

Issue Date FY: 2015 ( Subtotal = $1,566,560 )
2015	2015	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	002	6	9/24/2015	COMPETING CONTINUATION	$1,566,560
2015	2012	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	000	5	5/11/2015	NON-COMPETING CONTINUATION	$0
2015	2012	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	001	5	9/21/2015	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,566,560

Issue Date FY: 2014 ( Subtotal = $0 )
2014	2012	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	000	5	4/28/2014	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2012 ( Subtotal = $837,012 )
2012	2012	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	000	5	5/29/2012	NON-COMPETING CONTINUATION	$837,012
														Subtotal = $837,012

Issue Date FY: 2011 ( Subtotal = $937,760 )
2011	2011	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	000	4	5/26/2011	NON-COMPETING CONTINUATION	$937,760
2011	2010	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	002	3	9/16/2011	NON-COMPETING CONTINUATION	$0
2011	2009	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	001	2	9/16/2011	NON-COMPETING CONTINUATION	$0
2011	2008	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	003	1	9/16/2011	NEW	$0
														Subtotal = $937,760

Issue Date FY: 2010 ( Subtotal = $1,216,305 )
2010	2010	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	001	3	5/25/2010	NON-COMPETING CONTINUATION	$1,216,305
2010	2010	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	002	3	6/30/2010	NON-COMPETING CONTINUATION	$0
2010	2009	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	000	2	11/19/2009	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,216,305

Issue Date FY: 2009 ( Subtotal = $1,076,844 )
2009	2009	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	000	2	5/20/2009	NON-COMPETING CONTINUATION	$1,076,844
2009	2009	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	002	2	6/23/2009	NON-COMPETING CONTINUATION	$0
2009	2009	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	001	2	5/29/2009	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,076,844

Issue Date FY: 2008 ( Subtotal = $1,518,859 )
2008	2008	UNIVERSITY OF MANCHESTER	CHRISTIE BUILDING	MANCHESTER M13 9PL				GBR	Oral Diseases and Disorders Research	000	1	7/31/2008	NEW	$1,518,859
														Subtotal = $1,518,859

Grand Total All Awards = $10,281,261

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TOPS (Timing of Primary Surgery for Cleft Palate) trial Follow-up

Award Number: U01DE018664

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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