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E
Selected Programs Funding Preterm Birth Research

On August 10, 2005, the Institute of Medicine Committee on Understanding Premature Birth and Assuring Healthy Outcomes hosted a workshop on barriers to research on preterm birth (see Chapter 13 for discussion). Presenters at that workshop provided information on the funding of research on premature birth and preterm infants, the primary sources of which are the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and nonprofit voluntary health or philanthropic organizations, including the March of Dimes (MOD) and the Burroughs Wellcome Fund (BWF). The information that these agencies and organizations provided at the workshop are described below.

NATIONAL INSTITUTES OF HEALTH

An overview of the funding dollars that are being provided through the NIH, the National Institute of Child Health and Development (NICHD), and the Pregnancy and Perinatology Branch (PPB) of NICHD provides a snapshot of its grant portfolio in fiscal year (FY) 2004 for nonnetwork and network grants as well as some background about its FY 2004 R01 (grants for health-related research and development) grantees and trainees. Pinpointing how much NIH spends specifically on preterm birth research is difficult because it is codified under a broad general category called prenatal birth-preterm low birth weight that encompasses research concerned with normal and preterm labor, intrauterine growth retardation, and fetal and infant physiology and nutrition. Separating funding for preterm birth



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Preterm Birth: Causes, Consequences, and Prevention E Selected Programs Funding Preterm Birth Research On August 10, 2005, the Institute of Medicine Committee on Understanding Premature Birth and Assuring Healthy Outcomes hosted a workshop on barriers to research on preterm birth (see Chapter 13 for discussion). Presenters at that workshop provided information on the funding of research on premature birth and preterm infants, the primary sources of which are the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and nonprofit voluntary health or philanthropic organizations, including the March of Dimes (MOD) and the Burroughs Wellcome Fund (BWF). The information that these agencies and organizations provided at the workshop are described below. NATIONAL INSTITUTES OF HEALTH An overview of the funding dollars that are being provided through the NIH, the National Institute of Child Health and Development (NICHD), and the Pregnancy and Perinatology Branch (PPB) of NICHD provides a snapshot of its grant portfolio in fiscal year (FY) 2004 for nonnetwork and network grants as well as some background about its FY 2004 R01 (grants for health-related research and development) grantees and trainees. Pinpointing how much NIH spends specifically on preterm birth research is difficult because it is codified under a broad general category called prenatal birth-preterm low birth weight that encompasses research concerned with normal and preterm labor, intrauterine growth retardation, and fetal and infant physiology and nutrition. Separating funding for preterm birth

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Preterm Birth: Causes, Consequences, and Prevention and its consequences from the general category is not possible with the information currently available from NIH. Between FYs 2000 and 2004, funding in the category prenatal birthpreterm low birth weight increased from $306.5 million to $393 million in grants, contracts, and intramural research. Approximately 80 percent ($311.7 million) of these dollars came from the National Institute of Allergies and Infectious Diseases, NICHD, and the National Institute on Drug Abuse. PPB’s share of the NICHD contribution was about $70 million. The remainder of the NICHD funds is primarily allocated to research conducted in components of NICHD’s intramural research programs (Division of Epidemiology, Statistics, and Prevention Research). The PPB portfolio of grants relevant to preterm birth is divided between two areas. One area is parturition, in which basic research on the events leading to labor and delivery, which is fundamental to understanding preterm birth, is conducted. The other area is preterm birth, in which research directly related to preterm birth is conducted. In addition, two PPB networks are substantially involved in research on premature birth and its sequelae: the Maternal-Fetal Medicine Unit (MFMU) Network and the Neonatal Research Network (NRN). Both of these networks conduct clinical trials, as well as observational and mechanistic studies. The budget for MFMU in FY 2004 was about $10 million per year, approximately 75 percent of which goes to research on premature birth. The NRN FY 2004 research budget was approximately $8.5 million, with 75 percent going to research on infants born preterm ($6.4 million). In FY 2004, PPB supported 264 grants, which included new and ongoing grants; 41 (15.6 percent of the total PPB funding) were related to research on parturition or spontaneous premature birth. Twenty of these grants (7.6 percent of the total) were for research on parturition, and 21 of these grants (8 percent of the total) were for research on premature birth. PPB also supported 30 network grants (11.4 percent of the total dollars) that dealt with research on premature birth or premature infants. These were all U10 grants, which are cooperative programs between sponsoring institutions and participating principal investigators. The preterm birth– related grants can also be divided into two categories: nonnetwork preterm birth grants (a total of $8.4 million) and grants into the MFMU for preterm birth research (a total of $7.5 million). About $11 million, representing about 10.3 percent of the total for research on infants born preterm, was expended. Nonnetwork grants for research on infants born preterm totaled $4.6 million, and funds going to NRN for research on infants born preterm were $6.4 million. The portfolio of research on parturition was allocated into three general research areas: the uterus, which involves research on contractility and relaxation; fetal membranes, which involves research on fetal mem-

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Preterm Birth: Causes, Consequences, and Prevention brane rupture and amniotic fluid regulation; and the cervix, which involves research on cervical ripening. For the first category, the PPB funded 15 grants, including 1 F32 grant for postdoctoral research training, 2 K08 mentored career development awards, 3 R03 small research grants, 8 R01 grants, and 1 R01 supplemental grant. In the area of fetal membrane research, PPB funded three R01 grants; in the area of research on the cervix, PPB funded two grants, one F32 grant and one R01 grant. The spontaneous premature birth research portfolio can be broken down into seven areas: interventions, premature rupture of membranes, infection and inflammation/cytokines, epidemiology, transgenic mouse models, proteomics, and bioinformatics. The numbers and types of grants funded in each of these areas were as follows: interventions, two U01 grants; premature rupture of membranes, two R01 grants; infection and inflammation/cytokines, eight R01 grants; epidemiology, six R01 grants and one R01 supplemental grant; transgenic mouse models, one R03 grant; proteomics, one R01 grant; and bioinformatics, one K08 grant. The paylines, or funding levels, for these grants were the 14th percentile for R01 grants and the 20th percentile for R03 grants. In the intramural research program, NICHD conducts epidemiological, clinical. and laboratory research on those maternal and fetal diseases responsible for excessive infant mortality in the United States. The Perinatology Research Branch of the Division of Intramural Research focuses on the study of the mechanisms of disease responsible for premature labor and delivery, with particular emphasis on the role of subclinical intrauterine infection. The prenatal diagnosis of congenital anomalies is another major area of interest. NICHD also recently awarded a major contract and lease for continued support of the Perinatology Research Branch, located in Michigan. The new campus offers access to a patient population with a high rate of pregnancy complications and brings to bear the academic resources of three major universities: Wayne State University, the University of Michigan, and Michigan State University. These clinical and laboratory facilities opened in the spring of 2005. MFMU Network Some notable studies on preterm birth by the MFMU network have included the preterm premature rupture of the membranes (pPROM) trial, which demonstrated that broad-spectrum antibiotic therapy for pPROM prolongs latency and improves neonatal outcome; the bacterial vaginosis (BV) trial, which demonstrated that antibiotic treatment of asymptomatic BV does not reduce the rate of preterm delivery; and a progesterone trial, which indicated that weekly injections of 17-hydroxyprogesterone caproate

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Preterm Birth: Causes, Consequences, and Prevention reduced the incidence of recurrent preterm birth and improved the neonatal outcome for pregnancies at risk because of a previous preterm delivery. Neonatal Research Network Studies In the area of research on infants born preterm, notable studies included a surfactant trial that showed that lung surfactant prevents respiratory distress syndrome and an ongoing follow-up study of extremely-low-birth-weight infants. The latter study involved a long-term assessment of developmental and cognitive functions. In addition, NRN conducted a trial that demonstrated that nitric oxide administered by inhalation was of no benefit to extremely-low-birth-weight infants. R01 Grantees in FY 2004 A total of 28 R01 grantees and 2 U01 (R01 equivalent) grantees were supported in the areas of parturition or preterm birth research. Twelve were in the area of parturition and 18 were in the area of premature birth. In the area of parturition, the typical grantee was a Ph.D. and a full professor in a basic science department who received NIH-supported training or did postdoctoral research and conducted animal research. In the area of preterm birth, the typical grantee was an M.D. or Ph.D. associate or full professor in a department of obstetrics and gynecology, did postdoctoral training, and conducted human research. Trainee Grants for FY 2004 In 2004, 24 individual training and career development awards, which included new or ongoing awards, were supported. These included 3 F31 grants, which are for predoctoral fellowships; 2 F32 grants, which are for postdoctoral fellowships; 10 K08 grants, which are mentored, nonclinical research grants; and 9 mentored clinical research grants known as K23 grants. In the area of parturition, PPB funded four grants: one K31 grant, one F32 grant, and two K08 grants. In the area of premature birth, PPB funded only one K08 grant. NICHD also awarded one new institutional training (T32) grant in FY 2004. These grants provide support for basic or clinical pre- or postdoctoral training. PPB currently supports five of these T32 grants. Three are in the area of perinatal medicine or biology, one is in the area of perinatal epidemiology, and one is in the area of developmental neonatal biology. In total, this provides funding for about 19 postdoctoral trainees (M.D.’s or Ph.D.’s) per year. NICHD also supports a mentored clinical research development program for clinicians.

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Preterm Birth: Causes, Consequences, and Prevention In 2005, PPB supported two P01 grants relevant to research on preterm birth. One is entitled Initiation of Human Labor: Prevention of Prematurity. This grant focuses on investigation of the physiological and molecular bases for the initiation of human parturition and the causes of preterm birth. It involves studies of fetal adrenal activity, fetal signaling to the myometrium, fetal lung surfactant, and cervical remodeling and competency. The other P01 grant is entitled Overall Gene-Environmental Interaction to Human Parturition. Its overall goal is to identify the genetic and environmental risk factors that contribute in a multifactorial manner to preterm birth and to model the gene, environment, and maternal-fetal interactions that may contribute to the risk of prematurity. This research involves the analysis of the allelic frequencies of numerous polymorphisms in 16 candidate genes implicated in parturition. A new initiative that will be funded in 2006 is the genomic and proteomic network for premature birth research, which aims to accelerate the pace of research on premature birth by focusing on genomic and proteomic strategies in the human and providing for the scientific community a web-based database for data mining and the deposition of genomic and proteomic data. CENTERS FOR DISEASE CONTROL AND PREVENTION The CDC Division of Reproductive Health, Extramural, has funded several grants relevant to preterm research. The project Preterm Birth among Inner City Women: Bacterial Vaginosis, Stressors and Race was funded by multiple awards made through cooperative agreements with the CDC’s intramural program. The project investigates the hypothesis that there is a disproportionate risk of BV and preterm birth in selected populations, mostly the African-American population, which could be an expression of susceptibility resulting from immunosuppression and that immunosuppression may be exacerbated by the health-eroding effects of chronic stressful experiences. Functional Genomics and Proteomic Markers of Preterm Delivery and Their Variation by Race is a 5-year collaborative project investigating four pathways to preterm birth: infection, decidual hemorrhage, premature activation of normal parturition by maternal or fetal stress, and myometrial stretching. As part of the Pregnancy Outcomes in Community Health (POUCH) Study, CDC is funding a case-cohort investigation of the relationship between preterm delivery and selected immune system-related gene polymorphisms in a multiethnic community. The second goal of the project is to develop prediction models for preterm delivery.

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Preterm Birth: Causes, Consequences, and Prevention Another project is investigating whether providing 17-hydroxyprogesterone caproate to women with a history of spontaneous preterm birth seen in the context of routine prenatal care will result in a significant reduction in the rate of preterm birth. MARCH OF DIMES MOD receives between 800 and 900 letters of intent for requests for research funding. Of these, approximately 550 potential applicants are invited to apply for funding, and of those applications, 15 to 20 percent are funded (depending on the annual budget). The letters of intent are screened and selected by a committee. Applications are reviewed in the traditional peer review system by study sections. All applications are for investigator-initiated grants. The applicants are approximately 40 percent M.D.’s and 60 percent Ph.D.’s. The proposals span a range of subjects, all of which must be relevant to birth defects and reproductive health. This translates into the support of research on genetics, developmental biology, and neurobiology. However, research of a more clinically directed nature that addresses, in particular, the problems of neonates and problems related to pregnancy is also supported. Among these are studies that relate to premature birth, including both its potential causes and its consequences. These grants are awarded for 3 years and may be renewed three times, based on reapplications that compete with other renewals and new proposals. Research in social and behavioral sciences relating to the mission of MOD is also supported. Among these grants are included those that address such issues as the development of speech, hearing, vision, and intelligence, as well as social influences on health. These are also awarded for 3 years. The Basil O’Connor grants are directed toward support of newly independent investigators who are just emerging from their training but who have a faculty appointment on a tenure line, or its equivalent. These awards currently have a fixed budget of $75,000 per year for 2 years. The average annual award in 2005 for all grants comprising 410 projects, except the Basil O’Connor grants, was $83,000. In 1999, a special group of grants that considered the causes of prematurity was awarded. Those research studies needed to address external conditions but had to have biological plausibility, and they have been completed. Two of these generated successful research. A new initiative began in 2004 and offered six grants for research on causes of prematurity.

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Preterm Birth: Causes, Consequences, and Prevention BURROUGHS WELLCOME FUND The mission of BWF is to advance the medical sciences through the support of research and education by providing grants totaling $25 million to $35 million per year. Its major strategy is to invest in people, particularly young scientists working in undervalued or underfunded areas of research. BWF currently funds four competitive programs that rely on institutions to nominate their best young scientists. Two of these programs are bridging awards: they provide support for 2 years at the postdoctoral level and then continue for 3 years into the assistant professorship level. This funding is viewed as risk capital that young scientists can use to innovate and gather some preliminary data that help them to be more successful in obtaining subsequent NIH grants. Another of the four programs provides support to clinical investigators at the late assistant and early associate professor level who are engaged in translational research that spans the gap between the bench and the bedside. The fourth program supports assistant professors studying infectious diseases. In addition to these national programs, BWF provides support for science education within the state of North Carolina. The centerpiece of this effort is a competitive program for student science enrichment at the secondary school level. About 85 percent of the BWF funding goes to its competitive awards, and 15 percent of the funding goes to other catalytic efforts to improve the environment for BWF researchers. Within its national programs, BWF actively encourages the support of reproductive science as a broad category, but these grants are not specified for research in subcategories, such as prematurity.