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Advances in preventing pre-term births. Vitamin supplementation to decrease the risk of chronic lung disease. Controlling diabetes in pregnancy to produce healthier mothers and babies. Strides like these in the treatment of high-risk mothers and babies all have one thing in common – they were the result of multicenter clinical research trials.

Since 1986, a great deal of research to improve the care and outcomes of high-risk pregnant women and newborns, especially very low birth weight infants, has been organized and conducted through two networks in the National Institute of Health’s (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) – the 12-center Maternal Fetal Medicine Units Network (MFMU) and the 15-center Neonatal Research Network (NRN).

Following a rigorous review process, Women & Infants Hospital, a Care New England Hospital, and The Warren Alpert Medical School of Brown University, have recently received notification that their participation in both research networks has been renewed for the five-year cycle that begins in 2016. Women & Infants/Brown is one of only a few sites nationwide – and the only one in New England – to be part of both networks simultaneously.

“Women & Infants Hospital is committed not only to providing the highest quality, most compassionate care to the women and newborns of our region and to educating the next generation of caregivers, but also to forging discoveries that inform treatments today, tomorrow and for centuries to come,” said Mark R. Marcantano, president and chief operating officer, Women & Infants Hospital. “As one of the nation’s largest and most prestigious research facilities in high risk and normal obstetrics, gynecology and newborn pediatrics, we are gratified to again be selected for participation in such highly regarded networks as the Maternal Fetal Medicine Units Network and the Neonatal Research Network.”

"Some of the most inspiring outcomes of the partnership between Alpert Medical School and our affiliated hospitals, such as Women & Infants, are those where we can show that rigorous research translates directly to better care for patients," says Jack A. Elias, MD, dean of medicine and biological sciences at Brown. "Participating in these networks ensures that women and babies in Rhode Island have access to the leading edge of care."

Maternal Fetal Medicine Units Network conducts studies of pregnancy, maternal, fetal and infant health

The NICHD Eunice Kennedy Shriver Maternal Fetal Medicine Units (MFMU) Network is a consortium of 12 premier clinical centers across the U.S. whose charge is to investigate problems in clinical obstetrics. Brown/Women & Infants Hospital has been a participating center in the MFMU Network since 2001 and is the only MFMU center in New England. Dwight Rouse, MD, of the Division of Maternal-Fetal Medicine at Women & Infants Hospital and a professor of obstetrics and gynecology at the Alpert Medical School, is the Brown/Women & Infants principal investigator for the MFMU.

The Network conducts large randomized clinical trials aimed at improving outcomes for pregnant women and their offspring. With 140,000 births spread among its 12 centers, the Network is able to perform trials of sufficient size to reach definitive conclusions that result in health-improving practice changes locally, nationally and internationally. These trials directly inform the guidelines of the American College of Obstetricians and Gynecologists and clinical obstetric practice in the U.S. and abroad. As a result of MFMU Network trials, in the U.S. it is now routine to:

•  Use weekly 17-alpha hydroxyprogesterone caproate to prevent repeat preterm birth.
•  Administer antibiotics to women with preterm premature rupture of membranes to improve neonatal health.
•  Give women in early preterm labor magnesium sulfate to lower the chance that their baby will suffer from cerebral palsy.
•  Treat mild gestational diabetes to improve maternal and neonatal health.

Dr. Rouse said, “The two most recently completed MFMU Network studies will also directly improve practice. The Antenatal Late Preterm Steroids (ALPS) study showed that betamethasone administered to mothers delivering in the late preterm period (from 34 to 36 weeks gestation) lowers the risk of respiratory problems in their babies. Of the 2,800 women in this study, 290 were enrolled at Women & Infants. The TSH study, presented orally at this year’s Society for Maternal Fetal Medicine Meeting but not yet published, showed that treating pregnant women with subclinical hypothyroidism does not improve the intelligence of their children at age five (as had been claimed), and therefore screening pregnant women for this condition is not warranted.”  

Neonatal Research Network conduct studies of newborn medicine

Abbot Laptook, MD, medical director of the neonatal intensive care unit (NICU), professor of pediatrics at the Alpert Medical School, and principal investigator for the Women & Infants/Brown Neonatal Research Network, said, “The Neonatal Research Network has conducted a number of important clinical trials which have improved the outcomes of sick newborns and changed how neonatologists care for their patients. Not all trials performed by the NRN have changed clinical practice; even when this occurs, the results are important to guide neonatologists as to what treatments are not helpful and should not be used.”

Treatments that have been demonstrated in NRN trials to help newborn infants include:

•  Therapeutic hypothermia: This trial demonstrated that cooling the brain from a normal temperature to 92.3oF for three days is the only treatment to be of benefit for infants with a serious brain condition at birth, encephalopathy.
•  Targeted oxygen saturations: This trial showed the risks and benefits of maintaining oxygen levels either high or low in extremely preterm infants requiring supplemental oxygen.
• Aggressive phototherapy: This trial demonstrated better outcomes of extremely preterm infants when phototherapy for yellow jaundice was used aggressively compared to conservative use.
•  Vitamin A supplementation: This trial demonstrated that administration of vitamin A over the first month of life decreased the risk of Bronchopulmonary Dysplasia (BPD, a form of chronic lung disease) among extremely low birth weight infants.
•  Prophylactic Indocin: Administration of low doses of Indocin (similar to aspirin) in the first 24 hours of life reduces the extent of severe intracranial hemorrhage among extremely low birth weight infants.
•  Inhaled nitric oxide: This trial helped clinicians understand when to start nitric oxide therapy for serious conditions affecting the circulation to and within the lungs among infants born at term.

Women & Infants has been selected to participate in the Neonatal Research Network for each five-year cycle since 1991.

For information about research at Women & Infants Hospital, visit womenandinfants.org/research.

About Women & Infants Hospital

Women & Infants Hospital of Rhode Island, a Care New England hospital, is one of the nation’s leading specialty hospitals for women and newborns. A major teaching affiliate of The Warren Alpert Medical School of Brown University for obstetrics, gynecology and newborn pediatrics, as well as a number of specialized programs in women’s medicine, Women & Infants is the 12th largest stand-alone obstetrical service in the country and the largest in New England with approximately 8,500 deliveries per year. A Designated Baby-Friendly® USA hospital, U.S.News & World Report 2014-15 Best Children’s Hospital in Neonatology and a 2014 Leapfrog Top Hospital, in 2009 Women & Infants opened what was at the time the country’s largest, single-family room neonatal intensive care unit.

Women & Infants and Brown offer fellowship programs in gynecologic oncology, maternal-fetal medicine, urogynecology and reconstructive pelvic surgery, neonatal-perinatal medicine, pediatric and perinatal pathology, gynecologic pathology and cytopathology, and reproductive endocrinology and infertility. It is home to the nation’s first mother-baby perinatal psychiatric partial hospital, as well as the nation’s only fellowship program in obstetric medicine.

Women & Infants has been designated as a Breast Imaging Center of Excellence by the American College of Radiography; a Center of Excellence in Minimally Invasive Gynecology; a Center of Biomedical Research Excellence by the National Institutes of Health (NIH); and a Neonatal Resource Services Center of Excellence. It is one of the largest and most prestigious research facilities in high risk and normal obstetrics, gynecology and newborn pediatrics in the nation, and is a member of the National Cancer Institute’s Gynecologic Oncology Group and the Pelvic Floor Disorders Network.
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