Three New National Children’s Study Centers with Diverse Locations: A Glimpse at the Opportunities and Challenges
In our continuing efforts to highlight the diversity of communities that are part of the National Children’s Study, this issue profiles three new Study Centers and their locations: University of Arizona, which is managing the Apache County and Pinal County locations in Arizona; Tulane University, which is managing the New Orleans, LA location; and Maine Medical Center, which is managing the Cumberland County, ME location. They are 4 of the 105 Study locations from across the country that have been selected to ensure a representative sample of children from all races, ethnicities, socioeconomic classes, and regions is followed throughout the length of the Study.
Dr. Fernando Martinez, the Principal Investigator (PI) at the University of Arizona Study Center in Tucson and professor of pediatrics and director of the University of Arizona’s Respiratory Center, says Arizona is a state that presents great opportunities for the Study, but interesting challenges, as well.
Fernando Martinez, MD
There is a large asthmatic population that lives in Arizona because historically, it was thought that if you had asthma, it was healthier to live in a warm, dry climate. Although this assumption has since been disproven, it has skewed the health of Arizona residents. This, in itself, will provide a unique population from which to gather data.
The state also has a sizable Native American community. In Apache County, more than 70 percent of residents are Navajo. Working with the Navajo will provide an opportunity to investigate environmental causes of obesity and type 2 diabetes, which are more common in this and other Native American groups, than in the general population. However, this unique opportunity also comes with inherent challenges.
“Native communities often have their own expectations and beliefs about research, and have their own way of understanding causes of diseases,” says Dr. Martinez. “Many think that the conduct and conclusions of previous studies have not respected their particular values. They need to believe the National Children’s Study is interested in establishing the relationships required to investigate illness in their community in a way that is respectful of their traditions.” According to Dr. Martinez, Native Americans have been reluctant to do genetic studies and provide biological samples because they’re concerned the data could be used in ways that could be hurtful to them, and may not result in any improvement in the health of the tribe. “There is a history of mistrust,” he says. Dr. Martinez’s team intends to develop partnerships with Native groups and use tools that are compatible with their culture. “It won’t work if the Native population says to themselves ‘here comes the federal government again’,” he says.
Given that the National Children’s Study is a 21-year-long project, conducting research in Arizona presents yet another challenge. It is a state with an influx of recent immigrants, including some undocumented ones, and the second fastest-growing state after Nevada. How to deal with a population that is very mobile due to their immigration status or work opportunities is an issue the Study investigators will have to face. One of their tactics will be to develop strong relationships with local social service organizations that have ties to minority communities.
Dr. Martinez says the university is well-prepared, and has “a live presence” in both Apache and Pinal Counties. Recruitment will begin in early 2012. The Study Center will be partnering with local community colleges to train local community members to carry out the studies. Dr. Martinez hopes the National Children’s Study will foster young people’s interest in careers in health care, and build research capacity for the tribe that will continue after the Study has concluded. “It’s a great opportunity to develop the local infrastructure,” says Dr. Martinez.
The Tulane University School of Public Health in New Orleans, LA, is another group of investigators participating in the National Children’s Study. LuAnn White, PhD, DABT, a professor and director of the Tulane Center for Applied Environmental Public Health, is the PI leading the Tulane Study Center.
LuAnn White, PhD, DABT and Pierre Buekens, MD, PhD, dean of the Tulane University School of Public Health and Tropical Medicine
Prior to Hurricane Katrina, New Orleans was a low-income city with many health disparities, according to Dr. White. Approximately 70 percent of the population was African American. “But, with Hurricane Katrina flooding 80 percent of the area, and everyone evacuating, much of the existing demographic data are no longer valid,” explains Dr. White. “No one really knows the demographics now.”
Indeed, things have changed, and part of the Center’s challenge will be to collect new demographic data. Since the devastation of the hurricane, there have been dramatic population shifts and rapid growth in some areas. New Orleans’ population is two-thirds its original size and birthrates have changed. Growth has been seen in both Hispanic and Vietnamese populations, whereas African Americans now only account for 55 percent of the demographic makeup.
Although the Tulane Study Center will face many of the same challenges other Study Centers face in terms of sustaining interest both in the near term until the Study gets underway and over the long term, the Study Center expects there will be some retention issues to contend with that are unique to New Orleans, given the instability of housing in the area. They are also aware of the challenge in educating people and getting them to think of this study not just in local terms but as being part of the larger, National Children’s Study and not a post-Katrina analysis. They want the community to understand that “the National Children’s Study will be the largest long-term study of environmental and genetic effects on children’s health ever conducted in the United States,” says Dr. White.
As a result of the hurricane, many people lost their homes and were forced to move several times. Children have had to change schools. And many residents have been without jobs. Stress levels have definitely been on the rise, and “a whole new set of questions to ask in terms of how maternal stress affects children’s health will need to be developed,” says Dr. White. “Before Katrina, poverty was seen just in the inner city; now it’s cutting across all demographics.”
“On the other hand, there are a few silver linings behind all this instability,” says Dr. White. People assumed that after all the flooding and accompanying mold, asthma rates would increase. Surprisingly, they haven’t changed, and likely it’s because so much has been demolished. Another positive outcome of the demolition has been the dramatic drop in lead poisoning.
An interesting bonus of the aftermath of Katrina is that “people in New Orleans have developed more of a community and civic-mindedness. They are willing to fight for things,” says Dr. White. “People and organizations who don’t normally partner with us have agreed to do so. The National Children’s Study is becoming one of the most collaborative projects.”
“Locating the Study Center in New Orleans is very symbolic,” says Dr. White. “We are so pleased to be a Center. It’s a testament that we have recovered from disaster.”
Of all the 105 Study locations across the country, Maine Medical Center in Cumberland County, ME, is the furthest northeast. Though a mostly rural county with a predominantly Caucasian population, it also encompasses the city of Portland, the largest metropolitan urban center in the state, and a magnet for African, Southeast Asian, Eastern European, and Middle Eastern refugees. Nowhere is this more apparent than in one of the local high schools, where almost 50 different languages are spoken.
Maine Medical Center National Children’s Study Team
With that sort of mosaic, it’s clear that one recruitment challenge will be to learn cultural competency in order to build trust and cooperation with the large number of communities, says John Bancroft, MD, chair of pediatrics at Maine Medical Center, and PI of the Study Center. In fact, one of the things he looks forward to is the interaction with other investigators throughout the year at meetings, and through conference calls and Webcasts, where other Study Centers addressing similar concerns can share ideas and learn from each other.
“Building community engagement is a critical step in the initial phase of the Study. We need them to feel involved and have a sense of ownership,” explains Dr. Bancroft. As such, the Center has been contacting a variety of stakeholders in the community, including physicians, hospitals, schools, faith-based organizations, and other community and civic organizations. The Center is also in the process of developing a community advisory board in order to fully understand what the major concerns are in the county and how to best address them. We’re still learning what the key messages are—what’s important to them in terms of their lives, their children’s and family’s health, says Dr. Bancroft.
One of the tools that the Center plans to use to help the investigators understand the demographics of the area is geocoding. The mapping technique pinpoints data such as socioeconomic and environmental factors (e.g., water source, distance from major roads) on a map of the area, and presents a picture of how different variables are distributed throughout the target area. They will be making recommendations about variables to be considered in the Study to the coordinating center, which will then select the neighborhoods to be included in the sample.
As part of its planning for the multi-year pre-recruitment phase, one of the hurdles the team anticipates is the winter snow, which recruiters will need to trek through when traveling to peoples’ homes. Last year, Portland recorded more than 100 inches of snow.
Maintaining participation is a challenge every Study Center will face throughout the term of this longitudinal Study, and one of the keys to managing this, according to Dr. Bancroft, will be consistency in the staff and volunteers working on the Study. The hope is that with the same people building relationships with the participants, a deeper trust and sense of commitment will be established, leading to continued interest and participation.
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Good to Know
Common Treatment to Delay Labor Decreases Preterm Infants’ Risk for Cerebral Palsy
Preterm infants born to mothers receiving intravenous magnesium sulfate, a common treatment to delay labor, are less likely to develop cerebral palsy (CP) than are preterm infants whose mothers do not receive it, reported researchers in a large National Institutes of Health (NIH) research network.1
The research was conducted by investigators in 20 participating research centers of the Maternal Fetal Medicine Units Network of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The 2,241 women in the study were at risk for preterm delivery between 24 and 31 weeks of gestation.
The researchers theorized that magnesium sulfate protects against CP because it can stabilize blood vessels, protect against damage from oxygen depletion, and protect against injury from swelling and inflammation.
CP refers to any one of a group of neurological disorders affecting control of body movement and muscle coordination. Although muscle movements are affected, CP is not caused by problems in muscles or nerves; there are abnormalities in the parts of the brain that control muscle movements that cause CP. Many people with CP suffer additional neurological disabilities, including mental retardation and epilepsy. In CP, the brain may be injured or develop abnormally during pregnancy, birth, or in early childhood; however, the causes of CP are not well understood.
For their primary calculation, the researchers grouped the proportions of infants with moderate and severe CP together with the proportion of infants who died. The researchers included the death rate in this primary calculation, because mortality among preterm infants is very high. The researchers found that a total of 11.3 percent of infants in the magnesium sulfate group had either moderate or severe CP, or had died at birth or were stillborn. In contrast, a total of 11.7 percent of the infants in the placebo group had moderate to severe CP or had died.
The results indicate that the risk of death occurring in the magnesium sulfate group (9.5 percent) did not differ significantly from those in the placebo group (8.5 percent). However, among the babies that did survive preterm births, moderate or severe CP occurred significantly less frequently in the magnesium sulfate group (1.9 percent vs. 3.5 percent). The study authors did not include mild CP in their analyses, as mild CP will often disappear with time.
These study results support the findings of an earlier National Institute of Neurological Disorders and Stroke study published in Pediatrics that reported that mothers of preterm infants who did not have CP were more likely to have received magnesium sulfate than were mothers of infants who had CP.2
The NIH study is the largest, most comprehensive study to date to analyze this inexpensive and commonly used treatment to reduce the occurrence of CP after preterm birth, according to the researchers. “This is a major advance,” said Catherine Y. Spong, MD, chief of NICHD’s Pregnancy and Perinatology Branch and an author of the study. “Our results show that obstetricians can use magnesium sulfate, which they have experience prescribing, to reduce the risk of a devastating condition—CP—in preterm infants.”Researchers are continuing to examine the roles of genetics, environment, and traumatic events early in brain development that may lead to brain malformations and abnormalities that result in CP. The National Children’s Study, which is investigating how genetics and environmental influences before birth and in childhood impact health, will contribute to the body of research in CP and other health conditions.
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1Rouse, D.J. , Hirtz, D.G., Thom, E., Varner, M. W. and Spong, C.Y., et. al. for the Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network. (2008) A Randomized, Controlled Trial of Magnesium Sulfate for the Prevention of Cerebral Palsy. New England Journal of Medicine, 359, 895-905.
2Nelson, K.B. and Grether, J.K. (1995) Can Magnesium Sulfate Reduce the Risk of Cerebral Palsy in Very Low Birthweight Infants? Pediatrics, 95(2), 263.
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