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Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants

Award Number: R01HD086088
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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¿ DESCRIPTION (provided by applicant): Extremely preterm infants (EPIs) (< 28 weeks' gestation) have increased susceptibility for multiple significant short- and long-term medical complications that significantly delay the development of essential milestones, such as oral feeding, required for discharge. Further, infants who develop bronchopulmonary dysplasia (BPD) are at even greater risk for oral feeding difficulties compared to gestationally aged matched controls. Despite the frequency of oral feeding difficulties in this at-risk population, there currently exists no objective assessment tool to predict when an infant may safely feed by mouth and only limited intervention strategies to improve feeding behavior. The overall goal of this research proposal is to pair the expertise of Co-PIs Drs. Steven Barlow and Jill Maron to develop an innovative, novel, personalized and integrative approach that directly addresses the important need for oral feeding treatment strategies for the EPI population. In this multicenter trial, 180 EPIs will be enrolled from three neonatal intensive care units (CHI Health St. Elizabeth, Lincoln, NE; Tufts Medical Center, Boston, MA; and Santa Clara Valley Medical Center, Santa Jose, CA). Infants will be randomized to receive either PULSED orocutaneous somatosensory stimulation (PULSED NTrainer(r)) previously developed in the Barlow Laboratory, or SHAM (blind pacifier) starting at 30 weeks' post- conceptional age (PCA) up to the achievement of full oral feeds or discharge home. Serial salivary samples (n=2/week) will be obtained concomitantly to examine the gene expression profiles of six biomarkers (AMPK, NPY2R, NPHP4, WNT3, PLXNA1, PLXNA3) previously shown by the Maron Laboratory to be associated with oral feeding success in the premature newborn. In Aim #1, we will test the hypothesis that infants who received PULSED NTrainer(r) intervention will have a shortened duration of time to achieve full oral feeds and that their salivary gene expression profiles will correlate with feeding success. Infants will be stratified based upon their gestational age, sex, and BPD status. In Aim #2, computational analyses of both clinical and gene expression data from Aim #1 will be performed to identify responders and non-responders to the PULSED NTrainer(r) intervention and to identify critical times in neurodevelopment when infants may most benefit from the intervention. Finally in Aim #3, infants will undergo Bayley III Developmental Screen at 18-24 months' PCA to assess both the long-term effect of the PULSED NTrainer(r) on feeding behavior and neurodevelopment and the accuracy of neonatal salivary gene expression profiles to predict impairments later in childhood. Infants will also be assessed with the NICHD NRN 18-month Feeding-Growth-Nutrition Questionnaire to further our understanding of the PULSED NTrainer(r) on long-term growth and feeding behavior.


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 = -$16,318 )
2024	2020	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	2200 VINE ST	LINCOLN	NE	68503	LANCASTER	USA	Child Health and Human Development Extramural Research	000	5	12/15/2023	NON-COMPETING CONTINUATION	-$16,318
														Subtotal = -$16,318

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	2200 VINE ST BOX 830861	LINCOLN	NE	68503	LANCASTER	USA	Child Health and Human Development Extramural Research	000	5	2/18/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $600,506 )
2020	2020	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	2200 VINE ST BOX 830861	LINCOLN	NE	68503	LANCASTER	USA	Child Health and Human Development Extramural Research	000	5	3/26/2020	NON-COMPETING CONTINUATION	$600,506
														Subtotal = $600,506

Issue Date FY: 2019 ( Subtotal = $559,987 )
2019	2019	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	2200 VINE ST BOX 830861	LINCOLN	NE	68503	LANCASTER	USA	Child Health and Human Development Extramural Research	000	4	3/25/2019	NON-COMPETING CONTINUATION	$559,987
														Subtotal = $559,987

Issue Date FY: 2018 ( Subtotal = $532,508 )
2018	2018	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	2200 VINE ST BOX 830861	LINCOLN	NE	68503	LANCASTER	USA	Child Health and Human Development Extramural Research	000	3	3/22/2018	NON-COMPETING CONTINUATION	$479,257
2018	2018	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	2200 VINE ST BOX 830861	LINCOLN	NE	68503	LANCASTER	USA	Child Health and Human Development Extramural Research	001	3	5/1/2018	NON-COMPETING CONTINUATION	$53,251
														Subtotal = $532,508

Issue Date FY: 2017 ( Subtotal = $500,442 )
2017	2017	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	2200 VINE ST BOX 830861	LINCOLN	NE	68503	LANCASTER	USA	Child Health and Human Development Extramural Research	001	2	6/21/2017	NON-COMPETING CONTINUATION	$50,045
2017	2017	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	2200 VINE ST BOX 830861	LINCOLN	NE	68503	LANCASTER	USA	Child Health and Human Development Extramural Research	000	2	3/28/2017	NON-COMPETING CONTINUATION	$450,397
														Subtotal = $500,442

Issue Date FY: 2016 ( Subtotal = $604,060 )
2016	2016	UNIVERSITY OF NEBRASKA LINCOLN	303 ADMINISTRATION BUILDING	LINCOLN	NE	68588	LANCASTER	USA	Child Health and Human Development Extramural Research	000	1	3/22/2016	NEW	$604,060
														Subtotal = $604,060

Grand Total All Awards = $2,781,185

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Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants

Award Number: R01HD086088

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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