Research and Clinical Trials

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Research is a vital component of the University of Maryland Children's Hospital (UMCH). Families that come here benefit from our commitment to understanding the fundamental nature of conditions that undermine children's health.

From asthma and oncology to HIV and teen violence, our work spans the whole gamut of problems affecting children. We're studying cardiovascular and neurological disorders, and conducting clinical trials on preventive vaccines. Our neonatal experts, who are always searching for ways to help babies thrive, run an institute dedicated to the study of sudden infant death syndrome (SIDS).

We have a Center for Minority Health Research, a National Brain Tissue Bank and a Center for Celiac Research. We rank among the top 10 academic, pediatric hospitals in the nation in our ability to secure federal funds, and among the top 20 hospitals overall.

We've highlighted three prominent research areas that illustrate some of the unique, cutting-edge work of our faculty and staff. Read more about them below.


 

Division of Adolescent and Young Adult Medicine

At the University of Maryland Children's Hospital, the Division of Adolescent and Young Adult Medicine is constantly involved in research that explores aspects of adolescent health, behavior, disease prevention, performance and attitudes towards health care, sexuality and HIV. The division participates in and designs studies that connect with young people and addresses their social and medical needs. 

What kind of research is the Division of Adolescent Medicine conducting?

The Division of Adolescent and Young Adult Medicine is one of 15 sites in the Adolescent Medicine Trials Network (ATN) for HIV and AIDS Intervention. The primary mission is to conduct research both independently and in collaboration with the research network. In addition ATN includes community research partnerships to HIV prevention and vaccine studies. ATN initiatives have included clinical trials for HIV infected adolescents who have acquired infections sexually and perinatally. This initiative is now expanding to study responses to vaccines.

With hepatitis as a major public health problem, a new protocol looks at the response to hepatitis B vaccine in youth who are not HIV+ but are at risk of acquiring the infection. This is the first time we are considering an immune response to hepatitis B, which is more prevalent than HIV. Routinely the hepatitis B vaccine is given to children in three doses with the expectation that they will have a response, but through a previous study (the REACH) we found that there are a percentage of youth who were given the immunization and did not respond to it. Some teens still did not have a response, even after a fourth booster was administered.

Currently, pediatricians are mandated to give the immunization to youth, but the follow-up to make certain of a response is not mandated. The new protocol was created to find out what the response would be if we gave adolescents an adult dose of the vaccine. What we hypothesizeis that the pediatric doses given were too small. Another arm to this study is combining the hepatitis B and hepatitis A vaccines and checking the response teens have to the combination.

Can you elaborate on some of the HIV trials you are part of?

One of our projects is called Project Impact for HIV+ youth. It is the first study in the country to examine adherence to medications and risk reduction in adolescents infected with HIV.

It consists of a curriculum that includes group sessions, individual sessions and home visits. In addition, we are including technology to help these teens build their skills in adhering to medication and to help them learn how to talk about their medical issues. These adolescents have been using Personal Digital Assistants (PDAs). The devices aid them just like they do adults to track appointments, keep notes, and stay organized. There is a special program on these PDAs designed to help with the use of medication. Not only are the youth reminded of appointments, but also there is a special note section where they can write any questions they wish to ask their providers. We hope to use this innovative way of skill building as a model for other health issues related to adolescent care. Examples include reproductive care, diabetes and asthma where there are major problems with adherence, such as taking daily medications for asthma, diabetes, etc. Because teens are so technologically savvy that they learn very fast, the acceptance rate is very good.

Another study is the Hormonal Ectopy Research (HER) study. It is a five-year research and service project funded by the National Institutes of Health, examining the biological factors that put girls at risk for acquiring a sexually transmitted infection (STI). A careful inspection of the ectopy area (where the tissue inside the uterus meets the tissue outside of the vagina) is done in girls between the ages of 12 and 18. The mucosal immunity of the vaginal area is being scrutinized in this study. Previous research findings show that the immune system in the vaginal and cervical areas is unique and differs from that of the blood. It is known that the ectopy is the most vulnerable area for acquiring an STI. This study's results could be the foundation of developing new products such as gels for preventing STIs.

Teens are seen every three months and receive screening and care for STIs. A photograph of the cervix is taken to determine if the size of the ectopy correlates with the acquisition of STIs. We are also looking at whether or not hormonal contraceptives impact the risk. This study also examines behavioral aspects that may put girls at higher risk, such as the use of alcohol and tobacco. In addition, counseling is offered for pregnancy prevention, safer sex and reduction of risk-behaviors.

The division also participates in research on counseling and testing for HIV, as well as consideration of innovative ways to determine new infections in HIV+ individuals by developing a detuned assay. Presently, efforts are being exerted in the division on an oral HIV test to differentiate the chronic from the recently infected. It is very cutting-edge.

We have a Prevention Team that educates teens about safer sex, STIs and other adolescent health issues at different venues in and around Baltimore. Our counseling and testing services (CTS) are also available and enable teens to be confidentially tested for HIV. The CTS team can test youth in the community during outreach events such as health fairs and presentations as well as test in the youth clinic on a walk in basis.

What makes the division unique?

Since the needs of teens differ greatly from children, the division is committed to fostering public and privatepartnerships to advocate for adolescents and their families. In a youth friendly environment, young people are treated with care and respect. We also respect the impact young people have on their own health care and keep several youth on our Community Advisory Boards.

Another unique feature of our division is the community research partnership called Connect to Protect,: (C2P). Currently, we are in Phase II of Connect to Protect: Baltimore. During Phase I, we looked at the community to see what kinds of HIV prevention services and programs are available for teens and compared this information with youth behavioral data in order to determine where youth are most in need and the resources available to protect them. Now in the Phase II, Connect to Protect: Baltimore will conduct a community assessment to find where youth are spending their time. The research team will work with community organizations to interview teens in the Baltimore City zip codes of 21217 and 21201.

We also educate communities and young people about the importance of vaccine development to protect the health of youth. Our aim is to see Baltimore benefit from vaccine development for diseases that drastically affect young people. Connect to Protect: Baltimore will be the foundation for future initiatives that will include addressing not only the need for youth to be vaccinated for diseases like hepatitis A and B, but HIV as well. It is important for the youth of the city and their caregivers to understand vaccines, and the Division of Adolescent and Young Adult Medicine at the University of Maryland hopes to address their questions and beliefs before and during any vaccine initiative.


Center for Vaccine Development

Back in 1974, Myron Levine, M.D., and Richard Hornick, M.D., established the Clinical Research Center for Vaccine Development at the University of Maryland Medical Center. In 1976, because of its expanded work-scope and size, the Clinical Research Center was renamed the Center for Vaccine Development (CVD).

The CVD rapidly became an international leader in vaccine research. It has earned a reputation for the genetic engineering of new vaccine candidates against cholera, typhoid fever, shigellosis and malaria, as well as for the innovative clinical evaluation of a variety of new vaccines.

The CVD is unique in that it incorporates within it the full range of vaccinology activities. It initiates basic laboratory science programs to generate new vaccine candidates and follows those candidates through clinical evaluation, field studies and, finally, public policy analysis.

The Center is dedicated to controlling infectious diseases that afflict children and adults throughout the United States and in developing countries. The Center is involved in projects to control cholera, typhoid fever, malaria, shigellosis, E. coli diarrheal disease and invasive infections (such as meningitis) caused by Haemophilus influenzae type b, pneumococcus and meningococcus. The CVD maintains field units in Chile and Mali, which help it to fulfill its mission in developing countries.

In 2000, the CVD received a $20.4 million, five-year grant from the Bill and Melinda Gates Foundation to develop a "stealth" measles vaccine. This vaccine is being designed to protect infants in sub-Sahara Africa and other developing regions of the world who are at high risk of developing severe or fatal measles, but who are too young to receive the current measles vaccine.

Despite the fact that there already exists a measles vaccine, about 900,000 infants and young children continue to die each year from measles in developing countries, particularly in sub-Sahara Africa. One of the reasons for this is that, based on World Health Organization recommendations, the current measles vaccine should not be given to infants younger than 9 months of age.

The period from about 4 to 8 months of age, however, represents a high-risk period for infants in developing countries, where measles is common and the chance of exposure is high. When measles is contracted during this young age, the disease is often severe. Up to 20 percent of exposed infants may suffer fatal outcomes.

CVD researchers think that it may be possible to successfully protect infants younger than 9 months of age using a new vaccine that applies advances in biotechnology. Instead of injecting the measles vaccine, researchers prefer administering DNA vaccines and "live vector" vaccines via mucosal surfaces -- either orally or by nose drops.

As Director of the Center for Vaccine Development and lead investigator of the Stealth Measles Vaccine Project, Levine is directing the effort to develop a mucosally delivered measles vaccine. Levine and a team of researchers are preparing for early clinical trials of the new vaccine to be conducted in Mali and Mozambique. It will take a collaboration of genetic engineers, immunologists, epidemiologists and clinical vaccine specialists from several different medical organizations around the world to complete the trials.


Division of General Pediatrics

In her role as a pediatric psychologist at UMCH, Maureen Black, Ph.D., has spearheaded and contributed to numerous research projects. The primary focus of her research has been on the role of nutrition in the growth, development and behavior of children from low-income families.

Black has conducted long-term studies of babies who don't grow normally (failure-to-thrive). She has observed their abilities, limitations and behavioral patterns. Black has also studied the importance of iron and zinc in children's diets. Her research into feeding disorders and obesity in children led her to establish an obesity prevention program.

Black is involved in research around the globe. In a study published in The Lancet (2002), she and colleagues from Peru found that children who don't grow well in the first two years of life experience cognitive deficits during their school-age years, which may affect their school performance. According to the United Nations Children's Fund, growth deficiency or malnutrition affects millions of children worldwide.

Black's studies of iron and zinc deficiencies have taken her to India and Bangladesh. In 1999, Black was the principal author of a study published in the journal of the American Society for Nutritional Sciences that looked at the ecological factors associated with early growth problems.

Zinc, a trace mineral that is found in the brain, contributes to the organ's structure and function. Some studies suggest that zinc deficiencies may lead to delays in cognitive development. Both zinc and iron are found in meat. Deficiencies in these minerals are common in countries like India and Bangladesh, where because of a combination of poverty and religious beliefs, many people don't eat meat.

Along with researchers at Johns Hopkins University, Black is conducting a long-term study in these countries on iron and zinc and cognitive development in children. There are currently about 280 children enrolled in the study in Bangladesh, and about 680 children enrolled in the study in India.

Adolescent Parenting

In addition to her research on nutrition, growth and development, Black also studies various issues surrounding teen pregnancy and parenting.

Black was the lead investigator of a study on preschool-age children who live with their adolescent mothers and maternal grandmothers. Her research team looked at the cognitive and behavioral development of children living in such three-generation households.

The study, which appeared in the April 2002 edition of Pediatrics, found that living in three-generation households did not protect children from any maltreatment associated with maternal depression. In fact, preschool children living with their mothers and maternal grandmothers had even more behavioral problems than their counterparts in two-generation households.

The study concluded that while adolescent mothers and their infants may initially benefit from living with grandparents, by the time the children are 4 or 5 years of age, it is better for young mothers to establish their own residence (often with a male partner). This makes it easier for them to achieve the tasks of adolescence and enter adulthood.

In an earlier study, also published in Pediatrics (2001), Black found that both home and clinic-based interventions were effective in getting adolescent parents to stop feeding their infants solid foods prematurely. And in a study published in the journal Child Development (1999), Black and her colleagues found that children whose fathers play an active role in their lives develop better language skills and have fewer behavioral problems than children who have weak relationships with their fathers. 

This page was last updated: July 12, 2013

         
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