SOURCES SOUGHT
A -- The National Standard for Normal Fetal Growth: Clinical Center
- Notice Date
- 9/17/2006
- 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
- ZIP Code
- 20892-7510
- Solicitation Number
- Reference-Number-NICHD-DESPR-EB-SS-2007-01
- Response Due
- 10/3/2006
- Archive Date
- 10/18/2006
- Description
- Background: The National Institute of Child Health and Human Development (NICHD) is interested in identifying whether there are any interested Small Business Concerns with the requisite capabilities serve as clinical center in a multicenter, prospective study to establish a national standard for normal fetal growth. Normal fetal growth is a critical component to a healthy pregnancy and the long-term health of the child. An objective assessment of normal and abnormal fetal growth has enormous utility in prenatal care, neonatal care and outcome-based research. How to define ?fetal growth restriction? is a long-standing challenge in modern obstetrics. ?Small-for-gestational-age?, defined as a birthweight or estimated fetal weight below the 10th percentile at a given gestational week, is commonly used as a surrogate to fetal growth restriction. The main problem with this definition is that babies with a weight less than 10th percentile are not necessarily growth restricted (e.g., constitutionally small but healthy babies). On the other hand, a weight above the 10th percentile does not necessarily mean a normal fetal growth. For example, the rate of fetal growth may undergo pathological decline in late gestation (say, from 75th percentile in early pregnancy to 25th percentile at birth). In such a case, the birthweight is still above the 10th percentile but the fetus may have suffered from growth restriction indicated by higher perinatal mortality and morbidity. The key to solving this problem is to develop a method that can identify growth potential for individual fetuses. The underlying concept proposed by Gardosi et al. was that fetuses who significantly deviate from their individual optimal fetal size at a given gestation are considered either overgrown or growth restricted. Mounting evidence demonstrates that this method is a significant improvement over the 10th percentile in identifying and classifying fetal growth restriction. However, no good standard currently exists for fetal anthropometric parameters measured longitudinally throughout pregnancy in a sufficiently large number of normal pregnancies in the U.S. The NICHD proposes to conduct a multicenter prospective study to establish a U.S. national standard for normal fetal growth. Objectives: The primary purposes of this study are: (1) to establish a U.S. national standard for normal fetal growth (velocity) and size for gestational age; (2) to create an individualized standard for optimal fetal growth; (3) to improve accuracy of fetal weight estimation; and (4) to construct an individualized standard for fundal height. This study will recruit two cohorts of women from 4 clinical centers. The first cohort will consist of 2,400 healthy, low risk pregnant women. Approximately 600 women each will come from the following race/ethnicity background: African American, Asian, Caucasian, and Hispanics. Women will be recruited in the first trimester and followed up through pregnancy. Each woman will receive 5 scheduled ultrasound exams, which include 2-dimensional (2D) and 3-dimentinoal (3D) fetal anthropometric measurements. Uterine artery and fetal Doppler studies will be performed at selected gestational weeks. After delivery, neonatal anthropometric measures will be carefully taken. Obstetric and neonatal information will be extracted from medical charts. This cohort will be used to establish the standards of normal fetal growth and individualized standard for optimal fetal growth. The second cohort will include 800 women with existing conditions or environmental factors that are likely to affect fetal growth, either growth restriction or overgrowth. These women will follow the same protocol as the low risk cohort. The high risk cohort will be used as a testing group for the new standards and to identify cut-off estimated fetal weight percentiles below or above which risk of poor perinatal outcomes is elevated or significantly increased. Requirements: To be deemed capable to serve as one of four anticipated research sites for this study, a Small Business Concern must submit a written capability statement that clearly demonstrates their ability to: 1) within 24 months, recruit at least 500 pregnant women of mixed race/ethnic background in the first trimester; 2) randomize and interview subjects to collect information; 3) conduct 5 scheduled ultrasound exams on each subject throughout pregnancy, including 2D and 3D fetal biometry and uterine and fetal Doppler studies; 4) conduct ultrasound exams by a qualified sonographer certified by the American Registry for Diagnostic Medical Sonography with specialty certification in Obstetrics; 5) collect maternal and cord blood samples and the placenta according to specific pathology protocols; 6) collect all interview and medical record data; 7) conduct neonatal anthropometric measures shortly after birth; 8) have demonstrated access to emergency obstetric care. 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 Charles Newman, Contracting Officer, at the address provided by 3:00 PM Local Time on October 3, 2006. The Capability Statement should be limited to no more than 15 pages and it should clearly address each of the competencies stated above. 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 may be set-aside or partially set-aside for small businesses.
- Record
- SN01146447-W 20060919/060917220113 (fbodaily.com)
- Source
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