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Sharing Developmental, Meta, and Video Data from Preterm Infants Enrolled in the SPEEDI Clinical Trial

Award Number: R03HD113705
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2023
PERIOD OF PERFORMANCE END DATE: 09/15/2025

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Sharing Developmental, Meta, and Video Data from Preterm Infants Enrolled in the SPEEDI Clinical Trial - Rigorously collected longitudinal developmental data from very preterm infants will propel the fields of child development and childhood rehabilitation forward in 3 ways: 1) Combining data sets to increase rigor of predictive models and determine individual and cumulative risk for developmental delay or Cerebral Palsy (CP), 2) Analysis of clinical trial outcomes using consistent outcome measures could replace the need for some comparative effectiveness studies, 3) Intervention data from multiple studies will provide data for preliminary modeling of personalized medicine rehabilitation interventions. However, to achieve any of these goals, sharing of longitudinal developmental data from cohort studies and clinical trials is crucial.1,2 The purpose of this proposal for Funding Opportunity Announcement (FOA) Number PAR-22-261 Archiving and Documenting Child Health and Human Development Data Sets is to ensure that data from this three arm multi-site clinical trial of 85 very preterm infants, funded by NICHD prior to NIH’s guidelines for data sharing, is made available to research teams who could use it to address research questions beyond the initial study aims.3 Now is the time to fund the transition of this exciting data from a private dataset into a shared data set allowing the wealth of secondary analysis or harmonization with data set from other clinical trials which likely already include sharing plans. For example NICU trials including sensory intervention4, parenting5, and combined6 trials could be compared with the parent project. In addition, research teams focusing on understanding development are excited to use this data set and videos to answer questions on topics ranging from language acquisition to fine motor development. Infants born preterm are at high risk of developmental delays with up to 20 percent of infants born very preterm diagnosed with cerebral palsy (CP) at 2 years of age. While the development of the Common Data Elements for CP (CDE_CP)7 have increased the rigor of individual studies, the use of these highly recommended outcomes also increases the likelihood of combining data sets. The parent project (R01 HD093624, NCT03518736) uses a combination of outcome measures from the CDE_CP which will enable harmonization with other data sets. In addition, the use of innovative outcomes that can be used to evaluate early problem-solving in infants and parent infant relationships starting in the NICU will allow for new and innovative developmental questions. Thus, researchers from a broad number of fields will benefit from sharing this data. The aims included in this proposal focus on what can be done with this data set alone. Aim 1) Provide an accessible dataset with longitudinal data on developmental measures including the recommended common data elements for CP (CDE_CP) and additional measures that are sensitive to change in children without CP. Since the 2017 publication of the International Guidelines for the Early and Accurate Detection of CP8, hospitals with NICUs around the world have been implementing the use of the General Movement Assessment (GMA) into research and practice. Public access to GMA videos from the NICU and at 10-14 weeks post term age combined with outcome data could drastically increase the ability to conduct research on the prognostic value of the GMA and the General Movement Observation Scale (GMOS) which many be more sensitive to change over time and can be scored from available GMA videos. The parent project includes GMA data at enrollment between 34-42 weeks of gestation, plus 1-2 videos at the most predictive age (10-14 weeks post term) and developmental outcomes at 12 and/or 24 months. Aim 2) Provide a shared data set with longitudinal assessment using the Hammersmith Infant Neurological Exam (HINE) that can be used to determine if the HINE is sensitive to change over time. Innovative longitudinal intervention studies, such as the parent project, are beginning to evaluate inter


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: 2026 ( Subtotal = -$2 )
2026	2023	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90033	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	1	3/20/2026	NEW	-$2
														Subtotal = -$2

Issue Date FY: 2025 ( Subtotal = $119,311 )
2025	2025	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90033	LOS ANGELES	USA	Child Health and Human Development Extramural Research	001	1	1/24/2025	SUPPLEMENT FOR EXPANSION	$32,325
2025	2025	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90033	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	1	12/19/2024	SUPPLEMENT FOR EXPANSION	$86,986
														Subtotal = $119,311

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST	LOS ANGELES	CA	90089	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	1	11/7/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $175,481 )
2023	2023	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST	LOS ANGELES	CA	90089	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	1	9/18/2023	NEW	$175,481
														Subtotal = $175,481

Grand Total All Awards = $294,790

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Sharing Developmental, Meta, and Video Data from Preterm Infants Enrolled in the SPEEDI Clinical Trial

Award Number: R03HD113705

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/20/2023

PERIOD OF PERFORMANCE END DATE: 09/15/2025

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