SOURCES SOUGHT
A -- RECOVERY: The National Standard for Normal Fetal Growth
- 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-10-23(b)
- Archive Date
- 3/16/2010
- Point of Contact
- Elizabeth S Shanahan, Phone: 301-402-6775, Lisa K 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 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: (1) to add monochorionic and dichorionic twin pregnancies to the study population; and (2) to enhance the investigation of nutritional factors on fetal growth by administering the dietary questionnaires to all participants. Originally, recruitment was restricted to women with singleton pregnancies, while the evaluation of nutritional factors was limited to only a quarter of study subjects. c.Projected requirements: •Identify and recruit monochronic and dichorionic twin pregnancies early in pregnancy and follow up throughout pregnancy with 7 follow-up visits and ultrasound exams until delivery; •Collect information on nutrient and supplement intake during pregnancy in all subjects (normal women, obese women and twin pregnancies), which will improve assessment of the impact of imbalances in maternal diet on adverse pregnancy outcomes, e.g., fetal growth, birthweight, and preterm birth. 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 previous successful experience in large prospective cohort studies in recruiting, retaining and following up pregnant women. The experience shall include, but not limited to, successfully recruiting minority women and twin pregnancies, conducting in-depth interviews and nutrition surveys multiple times throughout pregnancy, following up subjects in time according to a planned schedule, performing extensive ultrasound and Doppler fetal measures, obtaining high quality 2-D and 3-D ultrasound images that are suitable for research and publication, and collecting maternal blood samples multiple times and fresh placenta tissue and cord blood immediately after delivery. • 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. An experienced, qualified sonographer certified by the American Registry for Diagnostic Medical Sonography with specialty certification in Obstetrics shall be available at least half time for the study. The Sonographer shall be familiar with GE E8 machine and ViewPoint software for image saving and transfer. • Facilities: It is desirable that the offeror have access to a twin clinic in order to be able to recruit a sufficient number of twin pregnancies. The offeror shall have adequate research space and facility to conduct a prospective study, including office space for research staff and patient enrollment, lab facilities for blood and placental sample collection, processing and storage at -70 degree. An ultrasound exam room shall be available for this study. The offeror shall provide easy access to routine and emergency (24/7) obstetric care. • Other specific capability pertinent to the study include: 1)recruit, within 12 months, at least 30 monochorionic and 30 dichorionic twin pregnancies in the first trimester; 2)randomize and interview subjects to collect detailed information on demographic characteristics, medical and reproductive history, health behavior, stress and physical activities; 3)conduct 7 scheduled ultrasound exams on each subject throughout pregnancy, including 2D and 3D fetal biometry and uterine and fetal Doppler studies according to a standard protocol; 4)collect maternal blood 4 times during pregnancy and cord blood samples and the placenta according to specific pathology protocols; 5)collect all interview and medical record data; 6)conduct maternal anthropometric measures during pregnancy and neonatal anthropometric measures shortly after birth; 7)collect nutritional information once at the first visit and 4 follow-up visits; 8)provide documented statistics to meet the recruitment requirements; 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 also 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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