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$2.7 Million Collaboration Helps Deliver Healthy Babies
Research networks study prevention and treatments for maternal and infant complications
Six months pregnant, Stephanie Torres-Zapata was out shopping in College Station in August 2003 when she began feeling very odd.
Jon Tyson, M.D., and Susan Ramin, M.D.,
direct
programs that help high-risk mothers
and babies.
Photos by Nora K. Shire
She instinctively knew something was wrong and went to the emergency room (ER) at the College Station Medical Center. After an examination, the ER arranged for her to be taken to Memorial Hermann Hospital-Texas Medical Center by ambulance.
Upon arrival, Torres-Zapata, who has a 10-year-old son who was full term at birth, was informed about a trial in the Maternal-Fetal Units Network to help reduce effects of premature labor. She agreed to be a study participant.
After three days of monitoring, Torres-Zapata went into labor, and one-pound, nine-ounce Angelica was delivered by Caesarean section. This month, Angelica will turn 3 – a happy, active toddler.
Giving high-risk mothers and babies the care they need to reduce mortality and disability takes commitment and research focusing on challenges in the period just before and just after birth.
This work at The University of Texas Health Science Center at Houston will continue, thanks to two five-year competitive grant renewals totaling about $2.7 million from the National Institute of Child Health and Human Development (NICHD), a part of the National Institutes of Health (NIH).
Susan M. Ramin, M.D., the Berel Held Professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at the UT Medical School at Houston, is principal investigator (PI) for the Maternal-Fetal Medicine Units Network, which received $1,405,477. Larry C. Gilstrap, M.D., the Emma Sue Hightower Professor and chairman of the department, is co-PI of the grant.
Jon E. Tyson, M.D., the Michelle Bain Distinguished Professor of Medicine and Public Health, is PI of the Neonatal Research Network, which received $1,316,259. The co-PI is Kathleen A. Kennedy, M.D., professor of pediatrics and director of the master’s degree program in clinical research.
Participating in a clinical trial helped
Stephanie Torres-Zapata, left,
and her
daughter Angelica,
who was born
prematurely.
The networks were established in 1986 by the NIH to conduct multi-center trials and observational studies for evaluating treatment and management strategies. All information goes to the NICHD Data Coordinating Center, which analyzes the outcomes.
“In the mid-1980s, the NIH identified the need for a mechanism to rigorously assess therapies and diagnostic tests, which could only be evaluated in very large populations,” explained Tyson, who was among the original PIs as director of the Neonatal Network at the UT Southwestern Medical Center in Dallas.
When he was recruited to the UT Health Science Center at Houston in 1998, the NIH allowed him to expand the UT Southwestern site to include both Houston and Dallas and to direct both programs until the next grant cycle.
Of the 16 neonatal centers, Houston is now the second largest, conducting network trials at both the Lyndon B. Johnson General Hospital and Children’s Memorial Hermann Hospital.
Respiratory Problems
Successes of the Neonatal Network include clinical trials demonstrating important benefits from administration of nitric oxide to term infants with severe respiratory failure and vitamin A to premature infants at risk for chronic lung disease. Another trial studied the use of body cooling for severely asphyxiated infants.
Tyson and Kennedy directed the vitamin A trial and played major roles in the nitric oxide and body cooling trials, which identified about a 30 percent reduction in the likelihood of death among severely asphyxiated infants and about 30 percent reduction in the likelihood of disability among the infants who did survive.
“This is an extremely gratifying result that provides the best hope for substantially improving the outcome of these infants whose oxygen supply before birth is seriously compromised,” said Tyson, who also is director of the Center for Clinical Research and Evidence- Based Medicine; professor of pediatrics, obstetrics, and internal medicine at the Medical School; and professor of management, policy and community health at the UT School of Public Health.
Care for Pregnant Women
In describing the Maternal-Fetal Units Network trials, Ramin said, “This is cutting-edge research, and the NIH trial results have an impact on determining what health care pregnant women will get. Even negative findings are beneficial because they tell us what procedures or medications do not help or could be harmful.”
The major objectives of this network, which consists of 14 centers, are to reduce the rates of preterm birth, fetal growth abnormalities, neurological problems and maternal complications in pregnancy.
“We have access to 125,000 pregnant women each year in this network. Clinical topics are chosen which can be evaluated within four to five years,” explained Ramin, who is director of the Division of Maternal- Fetal Medicine and the Maternal-Fetal Medicine Fellowship Program.
Like Tyson, Ramin came to the UT Medical School at Houston in 1998 from UT Southwestern. Upon arrival in Houston, she began creating the infrastructure needed to submit a grant for a NICHD center.
Focusing on preterm birth and common conditions during pregnancy, current maternal-fetal network studies include: giving combined antioxidants – vitamins C and E – to pregnant women to reduce the risk of preeclampsia (a toxic condition in late pregnancy that is characterized by a sudden rise in blood pressure); giving progesterone supplements to women pregnant with more than one baby to lower the risk of early delivery and improve the health of their infants; giving Omega-3 in addition to progesterone shots to further decrease early deliveries in women who previously had a baby born spontaneously before the due date; and evaluating treatment strategies in pregnant women with mild gestational diabetes.
Although their networks are separate, Ramin and Tyson collaborate if Ramin is conducting a study of interventions to benefit the fetus; he helps coordinate the neonatal care. If a study or clinical trial requires a long-term follow-up, he is involved in evaluation of the outcomes. Each works closely with counterparts at the other centers in their respective networks, especially UT Southwestern. A third UT institution, the UT Medical Branch at Galveston, became a member of the Maternal- Fetal Medicine Units Network in April.
BEAM Trial
Stephanie Torres-Zapata is a good example of the kind of patient enrolled in the network trials. She participated in the Beneficial Effects of Antenatal Magnesium Sulfate (BEAM) Trial, testing whether magnesium LANKsulfate – the most commonly used drug in the U.S. to delay premature labor – might reduce the infant death rate or prevent cerebral palsy. The rate of cerebral palsy in extremely premature infants is approximately 20 percent.
During the weeks and months that followed Angelica’s birth, the baby experienced many problems – part of her intestines had to be removed due to an infection; glaucoma developed in her right eye; she developed liver failure; and at eight months old, mother and baby traveled to The Nebraska Medical Center for a liver transplant.
Until she was 2 years old, Angelica’s growth and motor skills were checked every month. Now she takes one anti-rejection drug daily. She has speech therapy. Once a month at St. Joseph Hospital in College Station, her blood is drawn and samples sent to her local pediatrician, Children’s Memorial Hermann Hospital and The Nebraska Medical Center. Every three months they come to Houston, where Angelica is seen by the liver team.
“Being a part of the BEAM trial was a support group for me,” recalls Torres-Zapata, “and helped my understanding of what was happening with my daughter.”
By Nora K. Shire