Wednesday, January 21, 2026 1/21/2026

Leveraging Data for Infants with Cleft to Grow and Flourish: The BLOOM Study

Award Number: R01DE033703
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2024
PERIOD OF PERFORMANCE END DATE: 04/30/2029

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Leveraging Data for Infants with Cleft to Grow and Flourish: The BLOOM Study - ABSTRACT Infants with orofacial clefts (‘cleft’) are at high risk of malnutrition. Over 5,000 infants are born with a cleft in the United States each year. By 3 months of age an estimated 27% of these infants are underweight when compared to World Health Organization infant growth curves (weight-for-age z-score ≤ -2). The reasons for this are multifactorial, and involve the anatomical impact of the cleft, lack of timely clinical care with the appropriate specialists, social determinants of health, lack of access to necessary resources (e.g., cleft bottles, breast pumps), caregiver factors, and infant health characteristics. We do not know which infants with cleft will develop undernutrition, which factors are most salient, how undernutrition impacts health outcomes, or how to prevent undernutrition in this population. The purpose of this project is to address these gaps. We aim to: (1) Predict which infants with cleft will develop undernutrition and determine associations between undernutrition and surgical outcomes via a large clinical retrospective cohort study (N~18,000); (2) Quantify associations between caregiver/infant factors and undernutrition, and quantify relationships between undernutrition and adverse caregiver/infant outcomes in a prospective cohort study of caregiver/infants (N=336); and (3) Determine the contribution of caregiver/infant factors to our clinical predictive model for undernutrition. Our aims complement one another and provide a holistic view of infants with cleft and their experience with undernutrition and adverse health outcomes. The retrospective cohort study in Aim 1 will leverage curated electronic health records from PEDSnet, a consortium of U.S. children’s hospitals and a database on over 12 million children with records from 2009 to the present. The prospective cohort study in Aim 2 will include caregiver/infant dyads and elicit caregiver/infant experiences from birth to 15 months of age. It will focus on information not in the electronic health record. This prospective cohort study will capture factors related to caregiver/infant feeding experiences, social determinants of health, frequency of infant infections, caregiver stress, caregiver quality of life and more. Aim 3 is an exploratory aim in which we will combine data from PEDSnet with data from our prospective cohort to examine caregiver/infant contributions to our clinical predictive model developed in Aim 1. Optimal nutrition in early life is a cornerstone of infant health. Undernutrition in US infants with cleft is unacceptably high and there is insufficient research on how to address this issue. Our study will address this gap and is responsive to NIH/NIDCR Notice of Special Interest for data science project in dental and craniofacial research. We will shed light on an under-investigated area in cleft research and generate a robust, new body of evidence on undernutrition and its impact on adverse health outcomes in cleft. Our findings will inform the development of a tailored, high impact intervention to ensure timely growth and health of US infants with cleft.


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 = $0 )
2026	2025	SEATTLE CHILDREN'S HOSPITAL	4800 SAND POINT WAY NE	SEATTLE	WA	98105	KING	USA	Oral Diseases and Disorders Research	000	2	12/4/2025	NON-COMPETING CONTINUATION	$0
2026	2025	SEATTLE CHILDREN'S HOSPITAL	4800 SAND POINT WAY NE	SEATTLE	WA	98105	KING	USA	Oral Diseases and Disorders Research	001	2	12/15/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $858,961 )
2025	2025	SEATTLE CHILDREN'S HOSPITAL	4800 SAND POINT WAY NE	SEATTLE	WA	98105	KING	USA	Oral Diseases and Disorders Research	001	2	4/18/2025	NON-COMPETING CONTINUATION	$773,066
2025	2025	SEATTLE CHILDREN'S HOSPITAL	4800 SAND POINT WAY NE	SEATTLE	WA	98105	KING	USA	Oral Diseases and Disorders Research	004	2	8/14/2025	NON-COMPETING CONTINUATION	$0
2025	2025	SEATTLE CHILDREN'S HOSPITAL	4800 SAND POINT WAY NE	SEATTLE	WA	98105	KING	USA	Oral Diseases and Disorders Research	003	2	8/12/2025	NON-COMPETING CONTINUATION	$0
2025	2025	SEATTLE CHILDREN'S HOSPITAL	4800 SAND POINT WAY NE	SEATTLE	WA	98105	KING	USA	Oral Diseases and Disorders Research	002	2	5/9/2025	NON-COMPETING CONTINUATION	$85,895
2025	2024	SEATTLE CHILDREN'S HOSPITAL	4800 SAND POINT WAY NE	SEATTLE	WA	98105	KING	USA	Oral Diseases and Disorders Research	000	1	3/5/2025	NEW	$0
														Subtotal = $858,961

Issue Date FY: 2024 ( Subtotal = $815,556 )
2024	2024	SEATTLE CHILDREN'S HOSPITAL	4800 SAND POINT WAY NE	SEATTLE	WA	98105	KING	USA	Oral Diseases and Disorders Research	001	1	8/27/2024	NEW	$0
2024	2024	SEATTLE CHILDREN'S HOSPITAL	4800 SAND POINT WAY NE	SEATTLE	WA	98105	KING	USA	Oral Diseases and Disorders Research	000	1	7/22/2024	NEW	$815,556
														Subtotal = $815,556

Grand Total All Awards = $1,674,517

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Leveraging Data for Infants with Cleft to Grow and Flourish: The BLOOM Study

Award Number: R01DE033703

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2024

PERIOD OF PERFORMANCE END DATE: 04/30/2029

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