Key Dates

RFA-HD-21-006 - Elucidating the Role of Nutrition in Care and Development of Preterm Infants (R01 Clinical Trial Optional)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

The purpose of this Notice is to inform the scientific community that the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) plans to reissue Funding Opportunity Announcement (FOA) RFA-HD-21-006, “Elucidating the Role of Nutrition in Care and Development of Preterm Infants (R01 Clinical Trial Optional)” with the following important change: the maximum project period will be 4 years instead of 5 years.

The Specific Areas of Research Interest to this FOA will be the same as RFA-HD-21-006.

The FOA is expected to be published in Fall 2021, with the application due date in Spring 2022.

The purpose of this FOA is to invite applications to address priority gaps in our understanding of the role of nutrition in the care and development of preterm infants.

These gaps include, but are not limited to, the following:

• Data to develop nutrient specifications for preterm infants. Unanswered questions include but are not limited to:
  • Are there models of in utero nutrient supply across gestational age?
  • Maternal nutritional status:
    • What is the relevance of maternal nutritional status to the determination of preterm infant nutritional needs?
    • Is there a connection between human milk content, maternal nutritional status, and preterm infant nutrient requirements?
  • Are there developmental issues in nutrient metabolism that will affect choice and form of nutrients and other bioactive substances provided either parenterally or enterally to preterm infants?
  • Are there circumstances that might require additional (supplemental) amounts of specific nutrients and, if so, are there differences in the form of supplementation used parenterally versus enterally?
  • Are there contraindications of any specific supplementation (levels, form, potential interactions with concurrent therapeutics/drugs) and, if so, do these differ by infant gestational age and birth weight?
  • What total parenteral nutrition (TPN) safety and handling protocols should be followed and do these differ for gestational age, birth weight, and TPN content?

• Clinical issues in meeting nutritional needs in preterm infants across the relevant stages of development. Specific issues include but are not limited to:
  • Formulations for parenteral feeding
  • Transition from parenteral to enteral feeding
  • The role of specific feeding options including:
    • Human milk (mother’s own milk [MOM] from the breast vs. expressed/pumped MOM vs. donor/banked human milk)
    • Human milk fortifiers
    • Human milk substitutes
  • Challenges, specifications, and indications for use of special feeding techniques (e.g., trophic feeding, transpyloric feeding, intravenous to gavage/breast, etc.).
  • The role of feeding practice and specific macro- or micronutrients in common clinical conditions associated with prematurity (e.g., necrotizing enterocolitis [NEC], retinopathy of prematurity [ROP], etc.).

• Current standards for assessing nutritional status and the impact of infant feeding. Unanswered questions include but are not limited to:
  • What are the best biomarkers and cut-offs for assessing nutritional status in preterm infants, including where relevant:
    • What are the best biological samples for assessment?
    • What is the relative value of status assessment vs. assessment of nutrient function within specific systems?
  • What are the best approaches to:
    • Assessment of outcomes relevant to feeding protocols (e.g., goals and targets of nutritional management, differences by stages of development, in hospital vs. post-discharge, etc.)?
    • Assessment of infant growth (i.e., methods and metrics, rationale, value, choice of method/metric for stage of infant growth, use of growth curves, measures of growth velocity, etc.)?
    • Assessment of intrauterine growth restriction (IUGR) and extrauterine growth restriction (EUGR) (e.g., metabolic outcomes, measurement methods, growth velocity and catch-up growth, etc.)?
    • Assessment of neurodevelopment and its relationship to infant growth, development, and body composition (e.g., neurological indices of nutritional health or malnutrition, nutrient needs for brain development and assessment of sufficiency, etc.)?
    • Assessment of immunologic developmental outcomes (e.g., assessment, metrics of immune competency, response to vaccines, and impact on interpretation of biomarkers of nutrient status)?
    • Assessment of the impact of nutrition on pulmonary maturity and development or recovery from bronchopulmonary dysplasia (BPD)?
    • Assessment of impact of nutrition on and by renal maturation?
    • Assessment of GI tract development including on and by nutritional status and the relative impact of feeding regimens on the ontogeny and health of the gut microbiome?

Applications are not being solicited at this time. 

Please direct all inquiries to:

Daniel J. Raiten, Ph.D.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

301-435-7586

[email protected]

Daniel J. Raiten, Ph.D.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-7586
Fax: 301-480-8791
Email: [email protected]