SOLICITATION NOTICE
A -- Respiratory Distress in Newborns and Its Relationship to Group B Streptococcal Colonization
- Notice Date
- 11/21/2006
- Notice Type
- Solicitation Notice
- 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
- RFPNICHD-2007-03
- Response Due
- 2/15/2007
- Archive Date
- 3/2/2007
- Description
- Background: The National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) has a need for clinical centers to participate in 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 at the time of illness and from asymptomatic newborns (controls) at the time of metabolic screening with a case:control ratio of 1:1. 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. The Request for Proposals, RFP NICHD-2007-03 will be available on or about November 24, 2006 at: http://www.fedbizopps.gov/. All responsible organizations are encouraged to submit a proposal that will be due February 15, 2007. This requirement is defined as code 541710 under the North American Industry Classification System (NAICS). Only electronic copies of the solicitation will be available. This notice does not commit the Government to the award of a contract. CONTRACTING OFFICE ADDRESS: Department of Health and Human Services, Office of Acquisitions, NIDDK, NIH, NICHD Contracts Management Branch EXECUTIVE Bldg., Room 7A07, 6100 Executive Blvd. MSC 7510, Bethesda, Maryland 20892-7510. POINT OF CONTACT: Ms. Lynn Salo, Contracting Officer, e-mail: salol@mail.nih.gov; address: NICHD Contracts Management Branch, 6100 Executive Blvd., Room 7A07 MSC 7510, Bethesda, Maryland 20892. (If hand carry/overnight delivery, last two address lines are: 6100 Executive Blvd., Room 7A07, Rockville, Maryland 20852.) No electronic copies accepted.
- Record
- SN01184706-W 20061123/061121220216 (fbodaily.com)
- Source
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