Medical Student Research Fellowship for Summer 2010
Mentor: Gregory ("Greg") L. Jackson, M.D., M.B.A. / Susan Raff, M.D.
/ William D. Engle, M.D.
Room number: Parkland Memorial Hospital Newborn Nursery
Mail Code: 9063
Phone number: (214) 590-8034
Project title: Analysis of Chorioamnionitis and Prolonged Rupture of Membranes as Risk Factors for Sepsis in Term Neonates
Human subjects IRB approved project number (where applicable): IRB is pending
Animal subjects IRB approved project number (where applicable): N/A
Project Type (patient-based research, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects) - Patient-based
Brief Description of Project:
A great deal of attention has been devoted to assessments of sepsis risk factors in the neonate, so that those who are likely to require diagnostic testing and antibiotic therapy can be correctly identified, and importantly, so that antibiotic therapy will not be used in those neonates not requiring it. There is general agreement that when clinical chorioamnionitis (presence of maternal fever ?38? during labor) is diagnosed, neonates should receive antibiotics after admission to the nursery. Another well-described risk factor for sepsis is PROM (prolonged duration of ruptured membranes ?18 hours). Although some studies have described populations of neonates in which PROM was the only reason antibiotic therapy was initiated, there is less agreement among clinicians regarding the necessity of treating these infants, as opposed to those exposed to maternal chorioamnionitis in whom, as noted above, antibiotics are typically given.
Currently, the Parkland Memorial Hospital Newborn Nursery (NBN) admits babies who are ?35 week's gestation and ?2100 grams. If maternal chorioamnionitis is not present, infants receive PCN in the delivery room, prior to admission to NBN. Neonates exposed to maternal chorioamnionitis have a blood culture obtained on admission and they are given ampicillin and gentamicin IM for 48 hours. If they remain asymptomatic, they are discharged at the routine time. Although the presence of PROM is noted in the infant's admission documentation, at the present time infants admitted to NBN with PROM do not receive antibiotics unless maternal chorioamnionitis also is present.
We are proposing a retrospective, chart-review study. Using the EPIC electronic medical record (EMR) currently in use at Parkland and in the Parkland clinic system, we will identify all patients who fit into the following groups: (1) PROM, no exposure to chorioamnionitis; (2) PROM and exposure to chorioamnionitis; (3) Exposure to chorioamnionitis, no PROM. In addition, a control group that will be matched 2:1 with Group 1 will be identified. As closely as possible, these patients will be matched according to route of delivery, gender, date and time of birth, and ethnicity. The primary outcome measure is development of confirmed or suspected sepsis either during hospitalization or by the first clinic visit following hospital discharge.
Importance / implications of the research: Although there will be no direct benefit to the subjects, the information obtained from this research may benefit future neonates who are at increased risk of sepsis. Importantly, it may assist clinicians in their decision on whether antibiotics are indicated for the PROM-exposed neonate.
Role of the student: The student will be involved in the database development and input for data collection. The student will also assist in analysis of data and be included in the process of developing a poster and scientific paper. As part of the project, we also anticipate that the student will participate in clinical rounds and conferences, as an adjunct to learning about clinical aspects of neonatal infections.