Charles Michael Cotten, MD

I am involved in 4 major areas of research:
1) Neuroprotection. Working with colleagues from Cell Therapies, we have added to Duke's experience participating in pivotal trials of hypothermia for term newborns with moderate to severe hypoxic-ischemic encephalopathy (HIE) by completing a phase I study of autologous cord blood cells for these infants, and developing and currently leading a multicenter, double-blind randomized clinical trial of autologous cord blood cells or placebo in term infants with moderate or severe HIE. We are currently initiating, w/ funding from Duke's CTSI support, the first phase I single center study of allogeneic cord tissue derived mesenchymal stromal cells for newborns with moderate or severe HIE who do not have autologous cells available.
2) Genomics. We at Duke have been in the NICHD Neonatal Research Network (NRN) since 2001. I led the NRN's development of an Anonymized DNA bank of samples collected from 1,000 extremely low birthweight infants, with phenotype information linked to the samples. This resource has been the basis for multiple candidate gene, and genome wide scan analysis, and has identified variants associated with severe retinopathy of prematurity and necrotizing enterocolitis.
3) New Technologies: I have collaborated with Drs. David Millington from Duke and Vamsee Pamula (a Duke Pratt School graduate), from BAEBIES Inc, on prototype new technology devices for use in newborn screening for lysosomal storage disease as well as multiplex chips for screening for hyperbilirubinemia and related conditions, as well as working with Dr. Pamula and Dr. Michael Freemark (Peds Endocrinology) on screening panels for hypoglycemia and hypothyroidism, and with investigators from UAB on an Acute Kidney Injury panel. Also, I am collaborating with Dr. Cynthia Toth in pediatric ophthalmology, and Pratt School investigators to develop and apply use of optical coherence tomography for retinal imaging that will assess associations between retinal neurovascular development, brain development, and neurodevelopmental outcomes. I am also currently working with the Duke FORGE and multiple Pediatric subspecialists on machine-learning and deep informatics analysis of electronic health records to quantify risk for subsequent complications and on development of algorithms to identify neonatal seizures from neonatal EEG tracings.
4)Microbiome in Micropreemies and health outcomes of periviable infants. I have worked with multiple epidemiology researchers to assess practice variation within our center, and within the Neonatal Research Network centers, to identify how variation in practice can influence outcomes, with a particular focus on antibiotic use. This work demonstrated strong associations between high empirical antibiotic use in infants with sterile cultures and subsequent morbidities and mortality. This discovery has led to strong collaborations and new initiatives by young faculty leading studies of the evolving microbiome, leading to hypothesis generation re: the microbiome and optimal growth in extremely preterm infants.
Education and Training
- Intern and Resident, Pediatrics, University of Miami, 1986 - 1989
- M.H.S., Duke University School of Medicine, 2006
- M.D., University of Miami, 1986
Selected Grants and Awards
- Duke Women's Reproductive Health Research Scholars
- The Hydrocortisone for BPD Respiratory and Developmental Outcomes Study (HYBRiD Outcomes Study)
- Unified Program for Therapeutics in Children
- The Transfusion of Prematures Early School Age Follow-Up (TOP 5)
- RTI NRN Capitation
- Darbepoetin Trial to Improve Red Cell Mass and Neuroprotectoin in Preterms (Darbe)
- Early Check: A Collaborative Innovation to Facilitate Pre-Symptomatic Clinical Trials in Newborns
- Early Check: A Collaborative Innovation to Facilitate Pre-Symptomatic Clinical Trials in Newborns
- Implementation of an Evidence-based Parentally Administered Intervention for Preterm Infants
- Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network
- Population Health Research Support - Study of Pregnancy and Neonatal Health (SPAN) Task A
- Analyzing retinal microanatomy in retinopathy of prematurity to improve care
- Hypoxic Ischemic Encephalopathy-Phase II-Robertson Foundation
- A Low Blood Volume Platform for Global Newborn Screening of Common, Treatable Conditions Phase II
- Multiplex Platform for Point-of-Care Newborn Screening of Hyperbilirubinemia
- Expanding thyroid testing in high risk newborns: total T3, free T4, TSH and TRAB
- Comprehensive, Near Patient Assessment of Severe Hypoglycemia in Newborns Using Low Blood Volume (Phase II)
- Near Patient Acute Kidney Injury Biomarker Analysis in Critically Ill Neonates- Phase II
- TOP Trial
- A Novel Digital Microfluidic Platform for Near Patient Acute Kidney Injury Biomarker Analysis in Critically Ill Neonates
- Growth Failure in Extremely Preterm Infants: Microbiomic and Metabolomic Analysis
- A rapid, ultrasensitive system for recurrent thyroid testing in high risk newborns
- Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia
- A Secondary Study to the Transfusion of Prematures (TOP) Study
- Linking Safety Practices to Adverse Events and Outcomes in Hospitalized Infants
- MICROBIAL SUCCESSION AND ADAPTIVE IMMUNE RESPONSES IN THE PREMATURE INFANT
- PTN TO#25: Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections
- PK of Sildenafil in Premature Infants
- Prospective Observational Study of Respiratory Support Provided to Premature Infants at Risk for Respiratory Distress Syndrome
- Phase II Stannosoporfin
- Temperature Monitoring with InnerSense Esophageal Temperature Probe
- The Duke Multidisciplinary Training Program in Pediatric Lung Disease
- PTN TO 13: PK of Antistaphylococcal Antibiotics in Infants
- 48-52 Month Follow Up Stannsoporfin 64,185-204
- PTN Task Order #5: Safety and Efficacy of High-Dose Acyclovir in Infants with HSV
- Multidisciplinary Neonatal Training Grant
- Data Coordinating Center for the Prematurity and Respiratory Outcomes Program
- Multiplex platform for point of care newborn screening of hyperbilirubinemia
- Accelerating Adoption of Comparative Effectiveness Research in Premature Infants
- Best Pharmaceutical for Children Act (BPCA): Use of Meropenem in Infants