St. David’s HealthCare NICU research is focused around imaging, devices, neuroprotectants, and life-saving advances to improve the high-risk infant and mother outcomes. Researchers across St. David’s are involved in studies of cutting-edge technologies and treatments.
Retinopathy of Prematurity: The RAINBOW Study
Retinopathy of prematurity (ROP) is a disease that occurs in premature babies. It causes abnormal blood vessels to grow in the retina, the layer of nerve tissue in the eye that enables sight. This growth can cause the retina to detach from the back of the eye, leading to blindness. The traditional treatment for ROP is laser therapy. Laser therapy is invasive eye surgery that targets the peripheral areas of the retina, slowing or reversing the abnormal growth of blood vessels. A known side effect of laser eye therapy is the loss of peripheral vision. St. David’s Medical Center NICU participated in the RAINBOW Study, which is a randomized controlled national study evaluating the efficacy and safety of ranibizumab, also known as Lucentis, compared with laser therapy for the treatment of retinopathy of prematurity. Ranibizumab is a recombinant humanized monoclonal antibody that inhibits the abnormal growth of blood vessels. The results of this study will be available in the near future.
The Change in Surgical Approach to Gastroschisis Over the Last Decade in Austin, TX and the Effect on Neonatal Outcomes.
Gastroschisis is a congenital defect of the abdominal wall where the abdominal contents, most commonly intestines, herniate through the defect. In recent years, the incidence of gastroschisis has been climbing and is now between 4-5/10,000 live births. There are two primary types of surgical repair for gastroschisis: primary closure of the abdominal wall within hours of birth and silo placement with staged reduction and closure days after birth. Although there have been no randomized controlled trials comparing the outcomes of patients treated with the two different types of repairs, a meta-analysis suggests that infants who undergo silo placement with staged reduction are slower to reach full enteral feeding volumes, may require more days on the ventilator, and have longer hospital stays. In the last 10 years in Austin, Texas, the surgical management of infants with gastroschisis shifted from primarily placing silos and performing staged reduction and closure to primary closure within hours of birth. The aim of this study is to compare the characteristics and morbidities of infants with gastroschisis over the last 10 years to determine changes in the outcomes of infants as the preferred method of surgical repair has changed.
Quality Improvement: Improving Oxygen Safety in the NICU
Management of oxygenation for premature infants cared for in the NICU is complex. Too much or too little oxygen is problematic, especially for infants born less than 28 weeks and less than 1500g. The level of oxygenation influences mortality and the development of morbidities including retinopathy of prematurity (ROP), chronic lung disease (CLD), neurodevelopmental outcomes, and necrotizing enterocolitis (NEC). The aim of this project is to improve the safety and effective use of supplemental oxygen therapy and to reduce the amount of time spent outside the oxygen saturation target range by applying alarm safety principles to pulse oximetry.
Umbilical Cord Blood Gene Sequencing
Umbilical cord blood is a unique source of stem cells, cells capable of transitioning into different cellular subtypes. These stem cells can be influenced by events in both the fetus as well as the pregnant mother, prior to delivery. The prenatal environment can have lifelong influences on stem cells and other cellular subtypes via epigenetic programming, whereby protein expression can be changed within and around the cell, having long-lasting effects. A unique, National Institutes of Health-funded study aims to examine the genetic imprinting, or epigenetics, of umbilical cord stem cells in response to maternal medication received during the pregnancy. Our team has identified and selected a panel of genes known to be associated with neuropsychiatric disorders in adulthood. We hypothesize that the risk for certain disorders may be linked to cellular programming in the prenatal environment, and may be linked to maternal medication effects on the developing infant. We plan to begin actively recruiting pregnant mothers to participate in this study in the fall of 2017.
Infants who stay in the Neonatal Intensive Care Unit may be hospitalized for many weeks, and often months at a time before they are healthy enough to be discharged home. During their stay, these newborns may be exposed not only to medications, tests and artificial support, but also to environmental influences such as disturbed sleep/wake cycles, sounds that may be foreign to them such as monitors, and the incubator itself, which provides heat to the growing infant. The hospitalization represents the first time the baby’s brain undergoes postnatal experiences, which may affect the behavior or neurological outcome. At the Austin First Step clinic, professionals follow these infants and monitor their development in a research-oriented setting. The goal is to learn more about how different issues that arise in the Neonatal Intensive Care Unit may affect the brain development of a growing child and then use the data to make improvements in care for infants most at risk.
We are participating in a project with Dell Medical School to study ways to improve access to long-acting reversible contraception (LARC) (i.e., an intrauterine device or hormonal implant) during the immediate postpartum period (i.e., after delivery and prior to hospital discharge) among Texas women enrolled in Medicaid. We are participating in evaluating an intervention utilizing community health workers, and delivered through Sendero Health Plans, to help pregnant women enrolled in Medicaid in Texas obtain desired immediate postpartum LARC. Another aim of this project is to document the process and identify facilitators and barriers for Medicaid-enrolled women to obtain immediate postpartum LARC in Travis County, Texas.
Maternal and Fetal Medicine
St. David’s Women’s Center of Texas at North Austin Medical Center, in collaboration with Austin Maternal-Fetal Medicine, has a robust perinatal research division currently engaging in women’s health research projects including:
The SMART study
This multi-center prospective observational study is designed to track birth outcomes and perinatal correlates to the Panorama prenatal screening test in the general population among 10,000 women who present clinically and elect Panorama microdeletion and aneuploidy screening as part of their routine care. The primary objective is to evaluate the performance of Single Nucleotide Polymorphism (SNP)-based Non-Invasive Prenatal Testing (NIPT) for 22q11.2 microdeletion (DiGeorge syndrome) in this large cohort of pregnant women. This is being done by performing a review of perinatal medical records and obtaining biospecimens after birth to perform genetic diagnostic testing for 22q11.2 deletion. Results from the follow-up specimens will be compared to those obtained by the Panorama screening test to determine test performance. Specific test performance parameters will include PPV, specificity, and sensitivity. The study involves a collaborative relationship between Natera, our research program, and the State of Texas Newborn Screening Program. This study is currently enrolling mothers under the care of MFM providers at Austin Maternal-Fetal Medicine.
The PartoSure study
The purpose of this multicenter FDA trial is to examine the Partosure test for prediction of preterm delivery within 7 or 14 days from testing and to compare it with traditional cervical length (CL) measurements by transvaginal ultrasound (15 mm cut-off). Over 800 women at risk for preterm labor were enrolled into this trial, with our site as the top recruitment location (out of 10 centers) with 200 enrollees. The test is now before the FDA for final approval determination.
The Twins Cerclage study
In this multicenter randomized trial, we, in collaboration with researchers from Thomas Jefferson University (coordinating center) and Columbia University College of Physicians and Surgeons, are examining the effectiveness of cervical cerclage placement in twin pregnancies complicated by cervical dilation. We will soon launch the multicenter trial aimed at cerclage placement in twins with a shortened cervix. This study is currently enrolling mothers under the care of MFM providers at Austin Maternal-Fetal Medicine.
The Preterm Premature Rupture of the Membranes (PPROM) Antibiotic Selection study
In this multicenter randomized trial, researchers at St. David’s Women’s Center of Texas are collaborating with researchers from University of Texas Medical Branch in Galveston to examine the effectiveness of Azithromycin versus Erythromycin in pregnancies complicated by preterm premature rupture of membranes.