SOURCES SOUGHT
A -- Respiratory Distress in Newborns and Its Relationship to Group B Streptococcal Colonization
- Notice Date
- 10/6/2006
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NICHD-SS-GBS
- Response Due
- 10/20/2006
- Archive Date
- 11/3/2006
- Description
- Background: The National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) is interested in identifying whether there are interested Small Business Concerns with the requisite capabilities to assist in conducting a clinical study relating respiratory distress in newborns to group B streptococcal colonization. Phospholipids from group B streptococcal (GBS) cell wall cause pulmonary hypertension in experimental animals. When exposed to penicillin, Streptococcus mutans releases phospholipids immediately. Preliminary data from a NICHD multi center study have shown that 8.8% newborns colonized by GBS at birth had signs of respiratory distress within 48 hours after birth (cases). In 60% of the cases, oxygen supplementation was used, in 5% mechanical ventilation was required, and in 2% persistent pulmonary hypertension was diagnosed. Compared with light colonization, heavy colonization increased the rate of respiratory distress 1.73 fold, a discharge diagnosis of respiratory disorder 2.02 fold, a blood/CSF obtained for culture 1.54 fold and antibiotic administration after birth 1.87 fold. Penicillin use during labor was associated with a 2.62 fold increase in respiratory distress in the colonized newborn. These findings support the association of neonatal respiratory distress with ?asymptomatic? GBS colonization and with penicillin use during labor. We hypothesize that newborns colonized with GBS receive bacterial phospholipids leading to pulmonary hypertension and respiratory distress, especially in the situation of newborns of penicillin-treated mothers. Objective: The proposed study aims to relate the levels of serum bacterial phospholipids to the occurrence of respiratory distress in newborns of mothers colonized by GBS. The study will examine the pathologic effects of "asymptomatic" carriage of GBS and the effects of penicillin during labor on the occurrence of respiratory distress in newborns. Scope: It is estimated that ~320 newborns of > 32 weeks gestation with respiratory distress within 24 hours after birth and ~1600 mothers who are GBS carriers will need to be recruited within 12 months. To achieve that, about 8,000 mothers of >32 weeks gestation will be cultured for GBS carriage by obtaining vaginal and rectal swabs on admission to the labor and delivery room. Their newborns will be swabbed from 4 surface sites (throat, anus, ears and umbilicus) shortly after birth before the first bath to identify those who are colonized with GBS [and those who are not]. Maternal and cord blood samples will be collected from a random sample of 10% of newborns born to colonized mothers (about 160 newborns) and an equal number of non-colonized randomly selected newborns, penicillin treated and untreated groups(130 samples from each group). A 0.25 mL blood sample designated for this study will be collected from newborns with respiratory distress and from asymptomatic newborns (controls) with a case:control ratio of 1:1 at the time of metabolic screening. Medical records of the symptomatic newborns and the controls, penicillin treated and untreated mothers and newborns; and selected newborns of colonized and non-colonized mothers will be reviewed for demographic, clinical and epidemiological characteristics. Capability Requirements: To be deemed capable to serve as an anticipated clinical site for this study, a Small Business Concern must submit a written capability statement that demonstrate the ability to: 1) within 12 months recruit 8,000 mothers of > 32 weeks gestation for vaginal and rectal cultures in order to identify ~1600 mothers colonized with GBS and 800 newborns colonized by GBS at birth; 2) identify ~320 newborns of > 32 weeks gestation with respiratory distress within 24 hours after birth, select asymptomatic newborns as controls at a case:control ratio of 1:1 and obtain blood samples from these newborns; 3) have the capacity to provide tertiary nursery care for these newborns; 4) identify newborns of penicillin treated mothers and equal number of newborns of untreated mothers; 5) obtain maternal and cord serum samples from newborns of mothers colonized with GBS, newborns of mothers not-colonized with GBS, newborns of mothers treated with penicillin during labor and newborns of untreated mothers (about 160 newborns in each group); 6) obtain clinical, epidemiological data from medical records of above mothers and newborns. AT THIS TIME THE NICHD IS ONLY REQUESTING CAPABILITY STATEMENTS FROM SMALL BUSINESSES. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS. The applicable North American Industry Classification System (NAICS) code for this requirement is 541710. Therefore, the small business size standard for this announcement is 500 employees or less. See http://www.sba.gov/size/ for information on what is a small business and part 121.106 of the SBA's Small Business Size Regulations on how the SBA calculates number of employees. Small Businesses that meet the applicable size standard and believe that they have the capabilities described above are encouraged to submit a written Capability Statement to attention of Mya Hlaing, Contracting Officer, NIDDK Office of Acquisitions, NICHD Branch, (Overnight address: 6100 Executive Blvd., Room 7A07, Rockville, Maryland 20832) (Regular Postal service: 6100 Executive Blvd., Room 7A07, Bethesda, Maryland 20892) by 3:00 PM Local Time on October 20, 2006. The Capability Statement should be limited to no more than 15 pages and it should address each of the competencies stated above. Please submit an original and 5 hard copies. (See numbered Note #25) (No collect calls will be accepted, No facisimile transactions, No electronic copies will be accepted). If responses indicate a reasonable expectation of obtaining competitive offers from two or more responsible and capable small business concerns, the anticipated subsequent Request for Proposals will be set-aside for small businesses.
- Record
- SN01162577-W 20061008/061006220208 (fbodaily.com)
- Source
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