Notice Number: NOT-HD-11-005
Release Date: February 11, 2011
Response Date: March 31, 2011
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
This request is for information (RFI) and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), or the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The NICHD does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.
The purpose of this RFI is to seek input from the broader scientific community and public regarding the availability of products that are appropriate for clinical research on the use of probiotics as potential prevention therapy for premature infants at high risk for sepsis, necrotizing enterocolitis, and death. The NICHD Neonatal Research Network has developed a protocol to study probiotics as a preventive therapy for necrotizing enterocolitis and death in very low birth weight (VLBW) infants. A probiotic product that meets high quality standards for manufacturing and reproducibility is required for the study.
The NICHD Pregnancy and Perinatology Branch (PPB) supports research on preterm birth and disorders of the newborn. The lack of adequate prevention for infection, particularly necrotizing enterocolitis, has been identified as a major gap in the management of premature infants. Infection is a leading cause of death in premature infants and represents a major public health issue for such infants.
Probiotics are microorganisms found commonly in items such as yogurt and other fermented foods. Microorganisms are normally found in the gastrointestinal tract. If there is overgrowth or permeation of the mucosal barrier, infection can occur. The bacteria can translocate from the lumen of the bowel into the tissue and possibly the blood stream, potentially resulting in life-threatening infection. There have been several international studies suggesting beneficial effects of probiotics for VLBW infants. These beneficial effects include reduction in necrotizing enterocolits and death. However, concern has been raised regarding specific probiotics products and probiotic use in this fragile population.
Currently, there are no FDA-approved probiotics labeled for use in the premature population. Probiotics studies to date in VLBW infants have utilized GRAS (Generally Regarded As Safe) preparations. Concern regarding reproducibility, manufacturing standards, and consistency of quantity of colony- forming units have been raised as potential drawbacks to use of GRAS products for such vulnerable preterm infants.
A stable, product for potential use in premature infants, meeting FDA standards, is desired for testing in a multi-center trial in the U.S. population of premature infants planned by the NICHD Neonatal Research Network. The current network was funded in response to RFA-HD-04-010.
The NICHD is especially interested in concrete information and relevant suggestions that would help to identify potential partners and interested parties for a probiotic clinical trial in premature infants. The following information is requested:
Submitting a Response
Please provide your response to this RFI no later than March 31, 2011. Responses should be submitted as an email attachment in PDF format. Please limit responses to 10 pages or less. Emails should be sent to NICHDprobiotics@mail.nih.gov. Please indicate “NICHD RFI: NOT-HD-11-005” as the subject line for your email.
NICHD will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder’s submission. However, responses to the RFI submitted may be reflected in future solicitation(s). NICHD may contact any responder for the sole purpose of enhancing NICHD’s understanding of your RFI submission. The information provided will be analyzed and may appear in reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Specific questions about this RFI should be directed to:
Rosemary D. Higgins, M.D.
Pregnancy and Perinatology Branch (PPB)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
National Institutes of Health
6100 Executive Boulevard. Room 4B03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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