Posted April 7, 2009
Starting this month, thousands of newly pregnant Utahns and potential mothers-to-be will be asked to enroll in the largest study of children ever conducted in the country.
Parents who sign up for the National Children’s Study will join an effort to solve a new mystery in children’s health: How do kids’ genes interact with the water they drink, the air they breathe, the soil they play in and the products they use — to make them sick?
Scientists will be searching from womb to bedroom and beyond to understand why children increasingly suffer chronic diseases, such as asthma and learning disabilities, that have no other known cause.
Researchers will be figuratively — and sometimes literally — peering over mothers’ shoulders, from gauging how close they are to their child to probing how much television or junk food they allow. They’ll scan blood, urine, hair and nails to see what children or mothers are exposed to, from pesticides to drugs to stress.
“We recognize this is very, very intrusive,” says Sean Firth, an epidemiologist and study project director in Utah. “We will become part of their lives.”
Every scrap of information that will be collected is thought to be linked to a particular disease, he says, whether it’s prenatal infection and autism, household dust and asthma, or family dynamics and child development.
“We are going to accomplish great things by pulling this off,” says Firth.
But the massive study — the
goal is to enroll 100,000 children nationwide and follow them to age 21 — also raises ethical questions: How can a parent commit their future child to tests and questions that not even researchers have dreamed up? And what do parents deserve to know about their children’s health and environment — and when?
‘Change the world: In Salt Lake County — one of seven national pilot sites — recruiters will start knocking on the doors of 7,000 households during the last week of April. It could take six months to reach every home in the study boundaries.
They will look for women ages 18 to 49 who are in their first trimester of pregnancy or women who are likely to become pregnant in the next five years. Teens who become pregnant during the study period will also be approached. Biological fathers will be invited, but don’t have to participate for their children to be included.
The study will attempt to address the changing nature of childhood diseases. Although children used to die or suffer from infectious diseases, now their biggest threats are chronic diseases, which arise from the interaction of genes and environment, according to the study.
South Salt Lake mom Bronwen Calver hopes Utah women enroll to possibly help her son or his future children. Julian, 13, has asthma and allergies. While his asthma led to hospitalizations for bacterial pneumonia when he was a toddler — he coughed so much he broke capillaries in his lungs — it’s under control now. Still, on bad-air days during the winter and summer, he uses an inhaler and stays indoors.
“I hear of more and more kids having asthma. You have to wonder if there’s something environmental causing this,” she says. “A lot of people don’t understand how debilitating asthma can be. It makes your world very, very small when you’re sick.”
To build support, the local research team has been meeting with elected officials and community leaders in churches, ethnic organizations and schools.
Julie Miller, principal of Wasatch Elementary in Salt Lake City, is ready to urge parents to participate. She sees more children at school with asthma, allergies and diabetes. “I care [about the study] because I’ve spent a lifetime working with kids. There are things we can do to change the world we live in that will have a better outcome for all of us.”
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Breast milk to bedsheets: But on the national level, researchers acknowledge recruitment will be a “significant challenge” due to the burden placed on families. Over two decades, participants are expected to meet with researchers about a dozen times for four hours each, in their homes or at a clinic; keep records of doctor visits and fill out dozens of questionnaires. In the first two years alone, participants will devote 38 hours.
Researchers will take environmental samples from children’s homes, and possibly day care centers and mothers’ workplaces. They will chart graffiti, traffic and recreation spots in the neighborhoods.
They will vacuum household dust from tabletops, floors and bedsheets; take samples of placentas and umbilical-cord blood; collect vaginal swabs during pregnancy and breast milk afterward. They will gauge children’s development, from language to motor skills, even videotaping mothers and infants playing.
Families will be paid $25 an hour for in-home and clinic visits and will receive gift certificates and other incidentals.
Because researchers don’t know what information they will want to gather in the future, parents and children will be told at each visit what to expect. They can bow out at any time, or decide not to participate in certain portions. Children will be asked their opinions around age 7, 14 and 18. If they say “no,” their parents cannot overrule them.
Asking consent before every visit makes the study “ethically stronger than much of what we do otherwise in research,” says Jeffrey Botkin, associate vice president for research integrity at the University of Utah. He raised such ethical issues at the national level as co-chair of the study’s ethics working group.
The commitment “sounds like a lot,” says Andrea Riddle, who is trying to become pregnant with her second child. Nevertheless, the 31-year-old from West Jordan hopes to join, believing research of this magnitude requires the intrusiveness. “It’s always better to know more about what’s affecting children, how children are getting sick, how the environment affects them.”
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Gift to the future: If Riddle joins the study, she would want feedback as scientists discover environmental factors that affect children’s health. “If they found your home is not safe — something in the air, pesticides close by that could cause problems with the child — I would hope they would [give] you the information right away.”
But beyond immediately sharing information like blood pressure, height and weight researchers are still working through how they will report other information, prompting criticism from the National Academy of Sciences (NAS). It reviewed the study last year at the federal government’s request.
“Parents are often eager to get research results, regardless of their clinical utility or the availability of effective intervention,” the NAS report said. The review also noted that researchers could be sued if they learn that certain exposures are dangerous and don’t alert families to them.
“They need to have a plan on what they’re going to do,” says Ellen Wright Clayton, co-director of the Center for Biomedical Ethics and Society at Vanderbilt University, who was on the NAS review panel.
She says her personal opinion is that parents should be told, for example, if an ultrasound detects fetal deformities or a blood test reveals anemia. That’s because those are known health effects or risks.
The study’s researchers agree, and also will share information about signs of illnesses or developmental delays. But it’s more complicated with other information. Most biological and environmental samples won’t be analyzed until years later — when and if funding becomes available — delaying when researchers learn of risks.
Another problem: There are no national reporting standards for some samples, such as organophosphates, a chemical used in pesticides, says Edward Clark, chairman of the U.’s pediatrics department and principal investigator of the Utah portion of the study.
So researchers will have to determine what levels are dangerous before reporting to participants — and potentially, neighborhoods.
Somewhere in the country, “We will have another Love Canal,” Clark predicts, referring to a New York neighborhood built on top of toxic waste. “Our pledge is to bring this [information] back in a responsible way so individuals and communities will be aware of it and can develop an appropriate response.”
Scientists will immediately analyze specimens that cannot be stored for long periods of time, including volatile organic compounds, according to Rod Larson, who is in charge of the study’s environmental monitoring in Utah.
Such gasses are emitted from products such as paint, cleaning supplies, furniture and carpet, and are known to cause cancer and organ damage, according to the Environmental Protection Agency. Participants will be told if levels are too high as soon as the information is available, Larson says.
Firth, the Utah study project director, says it wouldn’t make sense to share certain information too soon, when researchers don’t know what level is dangerous. “People [would] look at that and see a big chemical name and think, ‘Holy cow. I’m in trouble.'”
Clayton, who recently joined an advisory committee for the study, agrees and says parents should understand what they are signing up for.
“A lot of people participate in research because they think they’re going to learn something about their own health. … They need to realize that participating in this is a gift to American children and the future.”
hmay@sltrib.com
Date: April 4, 2009
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