SOURCES SOUGHT
A -- RECOVERY: The National Standard for Normal Fetal Growth (Data Coordinating Center)
- Notice Date
- 2/19/2010
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-DESPR-SS-10-23(a)
- Archive Date
- 3/16/2010
- Point of Contact
- Elizabeth S Shanahan, Phone: 301-402-6775, Lisa L Coleman, Phone: 301-435-6955
- E-Mail Address
-
es219j@nih.gov, lc304t@nih.gov
(es219j@nih.gov, lc304t@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- TITLE: RECOVERY The National Standard for Normal Fetal Growth (Data Coordinating Center) This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement. a.Background: 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 Twin pregnancies have become increasingly common since 1980, due to the use of assisted reproductive technologies. Twin gestations have substantially higher risks of perinatal and maternal morbidity and mortality. In particular, relative to singletons, twins on average are born with a lower mean birthweight, shorter gestation, and a higher rate of fetal growth restriction, are four times more likely to develop cerebral palsy, and have a seven-fold increased risk of infant mortality. Our understanding of twin fetal growth, however, is still limited, and only a few longitudinal studies of twin pregnancy have been conducted, most involving small sample sizes. The key to solving these problems 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. The results from the study will for the first time establish a U.S. national standard and have profound impact on patient management and research for years to come. b.Purpose and Objective : 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 multicenter, prospective study, which officially commenced on September 26, 2008, is being conducted at four clinical sites in the U.S. The study involves the recruitment and follow-up of (1) 2,400 low-risk, normal weight women with an equal number of White, Hispanic, African American and Asian race/ethnicity; (2) 600 obese women; and (3) 250 monochorionic and 250 dichorionic twin pregnancies. 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. Recruitment began on July 15, 2009 and is expected to last at least two calendar years. The objectives for this proposed acquisition are to enhance the current web-based data management system to ensure accurate and timely data collection from (1) potential new clinical sites; (2) the 250 monochorionic and 250 dichorionic twin pregnancies added to the study; and (3) the dietary questionnaires now being administered to all participants as part of the ongoing study. Originally, recruitment was restricted to women with singleton pregnancies at four clinical sites, while the evaluation of nutritional factors was limited to only a quarter of the study subjects. c.Projected requirements: •Manage, coordinate and monitor potential additional clinical sites in the study; •Expand the current web-based data management system to successfully support the potential addition of clinical sites to the study; •Collect in a timely manner the additional data and images associated with both the twin component of the study and the questionnaire to all study participants on nutrient and supplement intake during pregnancy; •Assist in continuous quality control procedures for the ultrasound measures. d.Anticipated period of performance: 24 month period e.Capability Statement/Information Sought: 1)To be deemed capable of providing the current need for the study the offeror must submit a written capability statement that clearly demonstrates the ability to:: • Experience: The offeror shall demonstrate experience in collecting and coordinating data for cohort studies with complex protocols, including repeated interviews of subjects, blood and placental collection and image transferring. The offeror shall have demonstrated, successful experience in transferring a very large number of 2-D and 3-D ultrasound images from multiple institutions to the data center through the internet using ViewPoint software. The offeror shall demonstrate his familiarity and expertise in the interface among multiple ultrasound machines, ViewPoint software, ViewPoint servers and main server. • Personnel: The offeror shall provide the name of the principal investigator, his/her professional qualifications and specific experience as a key investigator in large prospective cohort studies of pregnant women. The experience shall be supported by peer-reviewed publications in the area related to the current study. The offeror shall demonstrate that the proposed investigation team and staff have previous experience in carrying out such a prospective study and have in-house expertise in a sonographic image transferring, storage and retrieving system. • Facilities: The offeror shall demonstrate his capability in developing a state-of-the-art web based data coordination and management system for the collection, editing, and correction of data from the Clinical Centers. The offeror shall have a large image storage capacity for 2-D and 3-D ultrasound images. • Other specific capability pertinent to the study include: 1)develop and test a web-based system for the timely collection of images from 7 scheduled ultrasound exams on each subject throughout pregnancy, including 2D and 3D fetal biometry and uterine and fetal Doppler; 2)assist in continuous quality control procedures for these ultrasound measures; 3)test, refine and implement a biospecimen tracking system for blood and placental sample collection; 4)develop an appropriate randomization scheme and coding assignment that take into account strata, cohorts and race/ethnicity composition; 5)train research staff at the Clinical Centers to use randomization and data entry systems; 6)conduct site visits of the Clinical Centers to assure protocol adherence; 7)provide other essential logistical support, such as, scheduling conference calls and steering committee meetings along with the preparation of minutes for all such activities; If any responsible source believes it can perform the requirements they may submit three (3) hard copies of their capability statements (5 Page Limit) for consideration by NICHD to Elizabeth Shanahan, Contracting Officer, at the mailing and e-mail address provided within 10 days of publication of this Sources Sought Notice. Overnight deliveries should be mailed to the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Boulevard, Suite 7A07, Rockville, Maryland 20852. No collect calls or facsimile transmissions will be accepted. Respondents may submit their capability statements via email (PDF format) in addition to 3 hard copies Respondents’ must include DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZONE, etc) pursuant to the applicable NAICS code. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. 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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation(s). Confidentiality: 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..
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