Author Contributions
Below we detail the contributions made by each author for this manuscript.
This manuscript represents a pilot study from the NICHD Neonatal Research Network
(NRN) testing the feasibility of enrolling subjects and obtaining an aEEG recording within
the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and weekly
thereafter up to 36 weeks post-menstrual age. The study subcommittee members held
regular meetings, in person and via telephone, during protocol development and
implementation. The manuscript was reviewed and input obtained from all coauthors. The
following authors have made significant contributions as determined by the Uniform
Requirements for Manuscripts Submitted to Biomedical Journals:
•
Alexis S. Davis, MD MS Epi, is the study investigator at Stanford University and the Chair
of the NRN Preemie aEEG Protocol Subcommittee. She developed the study, managed
study implementation, conducted site training visits, and drafted the manuscript. As the
site investigator at Stanford University, she enrolled and monitored 18 subjects for this
study. Dr. Davis drafted the manuscript and received input from the authors below as
part of manuscript revision.
•
Marie G. Gantz, PhD, served as the primary statistician for the study, providing
statistical input for protocol development and completing the statistical analyses for the
paper. She developed the tables for the paper and provided critical revision to the
manuscript and approved the final version of the manuscript.
•
Barbara Do, MSPH, assisted in completing the statistical analyses for the paper. She
helped develop the tables for the paper and provided critical revision to the manuscript
and approved the final version of the manuscript.
•
Seetha Shankaran, MD, is the NRN Principal Investigator (PI) at Wayne State University
and a member of the Preemie aEEG Protocol Subcommittee. As the PI, she oversaw
enrollment and monitoring of 17 subjects for this study. She contributed critical
revisions for the manuscript and approved the final manuscript for submission.
•
Shannon Hamrick, MD, was the site investigator at Emory University. As the site
investigator, she oversaw enrollment and monitoring of 13 subjects for this study. She
contributed critical revisions for the manuscript and approved the final manuscript for
submission.
•
Kathleen A. Kennedy, MD MPH, is the PI at the University of Texas Health Science Center
at Houston and a member of the Preemie aEEG Protocol Subcommittee. As the PI, she
oversaw enrollment and monitoring of 16 subjects for this study. She contributed
critical revisions for the manuscript and approved the final manuscript for submission.
•
Jon E. Tyson, MD MPH, is the co-PI at the University of Texas Health Science Center at
Houston and a member of the Preemie aEEG Protocol Subcommittee. As the PI, he
assisted with enrollment and monitoring of 16 subjects for this study. Dr. Tyson
contributed critical revisions for the manuscript and approved the final manuscript for
submission.
•
Lina Chalak, MD, was the site investigator at the University of Texas Southwestern
Medical Center at Dallas and a member of the Preemie aEEG Protocol Subcommittee. As
the site investigator, she oversaw enrollment and monitoring of 13 subjects for this
study. She contributed critical revisions for the manuscript and approved the final
manuscript for submission.
•
Abbot R. Laptook, MD, is the PI at Brown University and a member of the Preemie aEEG
Protocol Subcommittee. As the PI, he oversaw enrollment and monitoring of 16 subjects
for this study. He contributed critical revisions for the manuscript and approved the
final manuscript for submission.
•
Ricki F. Goldstein, MD, is the NRN Follow-up PI at Duke University and a member of the
Preemie aEEG Protocol Subcommittee. Dr. Goldstein helped develop the protocol, and
helped oversee enrollment and monitoring of 9 subjects for this study. She contributed
critical revisions of the manuscript and approved the final manuscript for submission.
•
Susan R. Hintz, MD, MS Epi, is the NRN Follow-up PI at Stanford University and a
member of the Preemie aEEG Protocol Subcommittee. Dr. Hintz was involved in
developing the protocol, and mentoring of Dr. Davis during protocol implementation,
data analysis, and manuscript preparation. She contributed critical revisions of the
manuscript and approved the final manuscript for submission.
•
Abhik Das, PhD, is the principal investigator for the NRN Data Coordinating Center and
a member of the Protocol Subcommittee. Dr. Das oversaw all aspects of the statistical
analysis, provided critical revisions to the manuscript and approved the final version of
the manuscript.
•
Rosemary D. Higgins, MD, served as the Program Scientist for the NICHD NRN and a
member of the Protocol Subcommittee. Dr. Higgins helped developed the protocol,
oversaw compliance, and assisted with data edits from the sites. She also provided
critical revision to the manuscript and approved the final version of the manuscript.
•
M. Bethany Ball, BS CCRC, is the NRN Coordinator for Stanford University and a member
of the Preemie aEEG Protocol Subcommittee. She contributed to the design of the
project, the study manual and data forms, and served as a resource for data collection
related activity for the other NRN sites. As the coordinator, she participated in the
recruitment and implementation of the study at Stanford University, which enrolled 18
subjects. She provided critical revision to this study’s concept and to the draft
manuscript, and approved the final version of the manuscript.
•
Ellen C. Hale, RN BS CCRC, is the NRN Coordinator for Emory University and a member
of the Preemie aEEG Protocol Subcommittee. She contributed to the design of the
project, the study manual and data forms, and served as a resource for data collection
related activity for the other NRN sites. As the coordinator, she participated in the
recruitment and implementation of the study at Emory University, which enrolled 13
subjects. She provided critical revision to this study’s concept and to the draft
manuscript, and approved the final version of the manuscript.
•
Krisa P. Van Meurs, MD, is the PI at Stanford University and the vice-chair of the
Preemie aEEG Protocol Subcommittee. As the PI, she oversaw enrollment and
monitoring of 18 subjects for this study. Dr. Van Meurs was involved in developing the
protocol, and mentoring Dr. Davis during protocol implementation, data analysis, and
manuscript preparation. She contributed critical revisions for the manuscript and
approved the final manuscript for submission.
Disclosures
None
Acknowledgements
The National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD), the National Center for Research Resources, and
the National Center for Advancing Translational Sciences provided grant support for the
Neonatal Research Network’s Preemie aEEG Study through cooperative agreements. While
NICHD staff did have input into the study design, conduct, analysis, and manuscript
drafting, the comments and views of the authors do not necessarily represent the views of
the NICHD.
Data collected at participating sites of the NICHD Neonatal Research Network (NRN) were
transmitted to RTI International, the data coordinating center (DCC) for the network, which
stored, managed and analyzed the data for this study. One behalf of the NRN, Dr. Abhik Das
(DCC Principal Investigator) and Ms. Barbara Do (DCC Statistician) had full access to all of
the data in the study, and with the NRN Center Principal Investigators, take responsibility
for the integrity of the data and accuracy of the data analysis. The content is solely the
responsibility of the authors and does not necessarily represent the official views of the
National Institutes of Health.
We are indebted to our medical and nursing colleagues and the infants and their parents
who agreed to take part in this study. The following investigators, in addition to those
listed as authors, participated in this study:
NRN Steering Committee Chairs: Michael S. Caplan, MD, University of Chicago, Pritzker
School of Medicine (2006-2011); Richard A. Polin, MD, Division of Neonatology, College of
Physicians and Surgeons, Columbia University, (2011-present).
Alpert Medical School of Brown University and Women & Infants Hospital of Rhode Island
(U10 HD27904) – William Oh, MD; Kristin Basso, RN MaT; Angelita M. Hensman, RNC-NIC
BSN.
Duke University School of Medicine, University Hospital, University of North Carolina,
Alamance Regional Medical Center, and Durham Regional Hospital (U10 HD40492, UL1
RR24128) – Ronald N. Goldberg, MD; C. Michael Cotten, MD MHS; Kimberley A. Fisher, PhD
FNP-BC IBCLC; Gloria Siaw, BSN CRA; P. Brian Smith, MD MPH MHS; James L. Wynn, MD;
Helmrath Michael, MD.
Emory University, Children’s Healthcare of Atlanta, Grady Memorial Hospital, and Emory
University Hospital Midtown (U10 HD27851, UL1 TR454) – Barbara J. Stoll; MD, David P.
Carlton, MD; Yvonne Loggins, RN.
Eunice Kennedy Shriver National Institute of Child Health and Human Development –
Rosemary D. Higgins, MD; Linda L. Wright, MD; Stephanie Wilson Archer, MA.
RTI International (U10 HD36790) – Dennis Wallace, PhD; Jeanette O’Donnell Auman BS;
James W. Pickett II BS; Kristin M. Zaterka-Baxter RN BSN CCRP.
Stanford University and Lucile Packard Children's Hospital (U10 HD27880, M01 RR70, UL1
TR93) – David K. Stevenson, MD; Melinda S. Proud, RCP.
University of Texas Southwestern Medical Center at Dallas, Parkland Health & Hospital
System, and Children's Medical Center Dallas (U10 HD40689) – Pablo J. Sanchez, MD; Luc P.
Brion, MD; Lijun Chen, PhD RN; Nancy A. Miller, RN; Diana M. Vasil, RNC-NIC.
University of Texas Health Science Center at Houston Medical School, Children's Memorial
Hermann Hospital (U10 HD21373) – Katrina Burson, RN,BSN; Georgia E. McDavid, RN;
Patti L. Pierce Tate, RCP; Peggy Robichaux, RN BSN.
Wayne State University, Hutzel Women’s Hospital, and Children’s Hospital of Michigan
(U10 HD21385) – Beena G. Sood, MD MS; Rebecca Bara, RN BSN; Mary E. Johnson, RN BSN.