Pediatrics

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Research

The Division of Pediatric Pulmonology, Allergy and Sleep Medicine in the Department of Pediatrics at Indiana University School of Medicine conducts basic, translational and clinical research. Specific areas of study include cystic fibrosis, asthma, bronchopulmonary dysplasia, primary ciliary dyskinesia, specialized physiologic testing, allergic diseases and sleep disorders. The division has a history of participating in investigator-initiated studies as well as drug trials and is a part of the Cystic Fibrosis Foundation Therapeutic Development Network, the Food Allergy Research and Education Network, and the Pediatric Behavioral Sleep Research Network. The division has been awarded funding from the NIH, the Cystic Fibrosis Foundation, the American Lung Association, the American Academy of Allergy, Asthma and Immunology, and the Food Allergy Research and Education Network.

Leadership with Research Expertise

Dr. Stephanie Davis is the Division Chief for Pediatric Pulmonology, Allergy, and Sleep Medicine and the Vice Chair of Clinical Affairs for the Department of Pediatrics at IU School of Medicine and is an NIH and Cystic Fibrosis Foundation funded investigator. Under her leadership, the research group and expertise within the division has greatly expanded and now supports more than 70 research protocols.

Dr. Davis’ research focuses on both understanding early pathogenesis in lung diseases (such as cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia and preterm birth) and the development of novel endpoints that identify and predict disease processes. In addition to contributing to several multicenter trials and performing interventional studies and methodology assessments in early lung diseases, Dr. Davis and her team have extensive experience in the area of infant/preschool lung function testing and have led consensus groups in establishing guidelines for these measurements.

With more than ten years of experience mentoring various levels of academic trainees, Dr. Davis has mentored 18 assistant or associate level professors, several of which have received NIH loan-repayment, early investigator Cystic Fibrosis Foundation or K awards. The majority of Dr. Davis’ pediatric fellows have elected to stay at academic institutions throughout the United States and Canada, including Indiana University, Duke University, the University of North Carolina, Washington University, and McGill University.

Herman B Wells Center for Pediatric Research

The Pulmonary Inflammation/Asthma and Allergic Diseases Research Group within the Wells Center for Pediatric Research studies the initiation, pathogenesis and progression of these diseases to identify better ways to treat or prevent allergic symptoms. Research spans many areas–from examining the regulation of genes important for the development of T cells involved in allergic inflammation and the biology of cytokines and other factors that promote allergic disease to examining lung development and function and how changes contribute to lung reactivity to allergens.

Pediatric Translational Research Center

The Pediatric Translational Research Center is the flagship pediatric research facility located in Riley Hospital for Children. This is the primary site for most of the pediatric patient-oriented research conducted at IU School of Medicine, the Department of Pediatrics, and Indiana Clinical and Translational Sciences Institute. The Translational Research and Integrated Biology Lab facility is housed within this facility and is the site of the Division of Pediatric Pulmonology, Allergy and Sleep Medicine’s storage freezers, lab equipment and workspace for laboratory technicians.

Specialty Areas of Pulmonary Research

The Aerodigestive team in the Division of Pediatric Pulmonology, Allergy and Sleep Medicine aims to provide multidisciplinary care to pediatric patients with complex airway and gastrointestinal problems to improve clinical outcomes by coordinating evaluations and operative procedures while providing an educational environment for trainees entering the field of aerodigestive care. In addition, this team is tailoring its management approach to encourage the implementation of research protocols both as a single-center and as a participant in multicenter trials.

Allergic diseases are an important area of research in the Division of Pediatric Pulmonology, Allergy and Sleep Medicine at the IU School of Medicine. The faculty in this division are involved in basic and translational projects. Dr. Kirsten Kloepfer has received funding from the NIH and the American Academy of Allergy, Asthma, and Immunology for her studies related to the airway microbiome. Dr. Mark Kaplan at the Wells Center for Translational Research has been recognized internationally for his work on understanding the development and function of IL-9-secreting T cells in the development of allergic inflammation. Dr. Girish Vitalpur currently heads the FARE Center of Clinical Excellence at Riley. The food allergy program at Riley has compiled one of the country’s largest registries on children with peanut allergy and is expanding it to include other food allergies. The faculty are also involved in trials related to peanut desensitization therapies.

Pediatric asthma is highly heterogeneous in its severity, frequency of exacerbation, and degree of intervention required. IU School of Medicine pulmonologists and allergists perform more than 9,000 outpatient asthma visits each year. With rates of childhood asthma continuing to increase, methods of prevention are a focus of research within the division. Research includes investigations into the natural progression of the airway and gastrointestinal microbiome and its association with early wheeze. Investigators are also studying novel mechanisms that can reduce airway smooth muscle contractility. Clinically, asthma research is focused on quality improvement projects aimed at decreasing hospital readmissions for asthma, implementation of standardized weaning protocols for inpatient asthma care, and examination of clinical outcomes for the Riley High Risk Asthma clinic.

Pediatric Pulmonology faculty at IU School of Medicine work closely with neonatology to evaluate the natural history of preterm lung disease secondary to preterm birth in order to better understand early markers that define phenotype. Investigators participate in both single-center and multi-center work, providing opportunity for fellows. Faculty perform novel physiologic measurements in young children with different types of lung disease. Because early lung disease often carries into adulthood, the ability to better understand the pathophysiology and potential therapeutic markers is important.

Additional research is investigating how genetic variants contribute to the Bronchopulmonary Dysplasia phenotype, particularly on those with severe Bronchopulmonary Dysplasia, requiring home ventilation. Identifying genetic markers of severe Bronchopulmonary Dysplasia will provide an unparalleled opportunity to advance understanding of the role of genetic factors in lung disease associated with premature birth to allow more precise definition of the non-genetic factors involved and to apply this insight rapidly to the prevention and early, targeted treatment of severe Bronchopulmonary Dysplasia.

The Center for Infant and Preschool Pulmonary Function Testing, housed within the Division of Pediatric Pulmonology, Allergy and Sleep Medicine at IU School of Medicine, has been performing infant pulmonary lung function tests for more than 20 years. The lab is nationally recognized as a Core Laboratory for Cystic Fibrosis Foundation Therapeutics, and the expertise of the lab staff supports various clinical and research procedures. Areas of expertise include calibration techniques, performance of actual lung function tests and centralized interpretation and analysis of study data from infant and preschool lung function tests. Through a variety of diagnostic and investigational tests, baseline measurements as well as responses to therapeutic interventions are evaluated.

The Division of Pediatric Pulmonology, Allergy and Sleep Medicine at IU School of Medicine is involved with the retrospective chILD study and is engaged in developing a registry to participate in defining new treatments and better phenotyping for children battling these life-threatening diseases.

Recognized as one of the leading centers in the nation for providing state-of-the-art care, research, and leadership, the Indiana University Cystic Fibrosis Center is Indiana’s only Cystic Fibrosis Foundation-accredited pediatric care program and supports a number of affiliate sites throughout the state. The center’s team brings together physicians, researchers, advanced practice nurses, dieticians, social workers, respiratory therapists, pharmacists, child-life and mental health specialists to provide support on all fronts for children and families affected by Cystic Fibrosis.  The division supports several leading investigators in Cystic Fibrosis research. A major area of focus is the earliest stages of disease progression in infancy and early childhood. By improving understanding of early events and predictors of disease, developing better tools to detect mild disease, and supporting industry-sponsored trials of novel interventions in younger populations, this team of investigators can refine strategies to treat and potentially prevent disease progression.

Faculty in the Division of Pediatric Pulmonology, Allergy and Sleep Medicine perform clinical research internationally, including asthma studies in Honduras and Cystic Fibrosis registry studies in Latin America. Investigators are currently working on a cross-sectional case control study comparing baseline lung function among children with sickle cell anemia currently on hydroxyurea for at least a year and enrolled in the Novel Use of Hydroxyurea in an African Region With Malaria (NOHARM) study compared to sickle cell anemia controls not on hydroxyurea followed in the Mulago Hospital Sickle Cell Clinic (Uganda). The team is also working closely with investigators in Perth and Melbourne, Australia, to elucidate the impact of viruses and the microbiome on early lung disease.

Lung growth and development is an important area of current research with laboratories focusing on the pulmonary pathophysiology of lung disease that occurs following premature birth. Additionally, in collaboration with another division of Indiana University School of Medicine, this research program is studying the effects of maternal preeclampsia on the development of pulmonary and vascular dysfunction in infants.

With the availability of disease-modifying therapies for various neuromuscular disorders, the natural history of these conditions is changing. Division faculty are studying the predictive factors of pulmonary involvement as well as the changing pulmonary morbidity and outcomes in this new era of treating neuromuscular disorders. Research is focused primarily on Duchenne Muscular Dystrophy and Spinal Muscular Atrophy, two of the most common pediatric neuromuscular disorders. However, as the multidisciplinary neuromuscular disorders clinical program expands, investigators intend to broaden their epidemiological studies to other neuromuscular diagnoses.

Indiana University School of Medicine has the only Primary Ciliary Dyskinesia center in the state. The Pulmonology Division of the Department of Pediatrics is involved with a NIH-sponsored research program, the Genetic Disorders of Mucociliary Clearance Consortium, a North American consortium investigating the progression of Primary Ciliary Dyskinesia. Genetic mutations linked to this disease lead to a wide range of disease severity. IU School of Medicine is a leader for the pediatric arm of this research program in addition to supporting other research in Primary Ciliary Dyskinesia, including heterotaxy. Increasing understanding in the areas of genetics and early diagnosis of Primary Ciliary Dyskinesia may lead to the implementation of tailored individualized treatment plans for children and adults with this rare disease.

The Division of Pediatric Pulmonology, Allergy and Sleep Medicine is determined to help young patients suffering from pulmonary hypertension and participates in industry trials involving this disease. The division is in the process of applying for Pulmonary Hypertension Association (PHA) accreditation as a Pediatric Center of Comprehensive Care.

The pediatric sleep program at Riley Hospital for Children is one of the largest in the world with more than 3500 pediatric polysomnograms and more than 2000 patient visits completed each year. Riley also has one of the largest neonatal polysomnography programs in the world with almost 400 neonatal and infant polysomnograms completed each year. Faculty investigators in this area have published manuscripts on the determinants and outcomes of neonatal obstructive sleep apnea and are completing a study on polysomnograms in normal newborns to facilitate clinical decision making, providing a frame of reference for interpretation of these complex and expensive studies. Over the next few years this team will investigate the determinants and outcomes of the full spectrum of pediatric sleep disordered breathing. Almost 40 percent of patients presenting to a pediatric sleep clinic have insomnia, and investigators are studying the determinants of pediatric insomnia and the outcomes of various therapeutic interventions in this common clinical problem. Additional sleep research examines the development and implementation of evidence-based care for children’s sleep disorders with a focus on the primary care setting. Active studies include 1) the use of a computer decision support system to identify obstructive sleep apnea in primary care; 2) management of infant night wakings in primary care; and 3) behavioral sleep treatment as a therapeutic for children with disruptive behavior disorders.

Clinical Trials

IU School of Medicine Pediatric Pulmonology, Allergy and Sleep Medicine faculty lead and participate in a number of research trials ranging from asthma to Primary Ciliary Dyskinesia and Cystic Fibrosis, allowing pediatric pulmonary fellows to focus in their specific area of interests.The division is involved in both investigator-initiated and pharmaceutical sponsor trials with more than 70 ongoing protocols. The division also has a dedicated research team that includes a research director, eight research coordinators/nurses, two respiratory therapists and a regulatory specialist. This team has wide-ranging experience in recruiting patients for research studies. The research team represents more than 60 years of combined research and clinical experience.

Number of Protocols Per Focus Area
Cystic Fibrosis 37
Allergy 5
Primary Ciliary Dyskinesia 3
Asthma 4
Sleep 5
Lung Growth 16
Pulmonary Arterial Hypertension 1