The Best Pediatric Specialty Care
Out There, is Right Here.

 

   

Deeply ingrained in our culture at CCS, is our commitment to clinical research. We are part of the Pediatric Clinical Trials Networkand our collaboration with NHRMCis always pushing us to uncover better ways to administer treatment and nutrition or prevent diseases. Our number one priority is the safety of our medically fragile patients and our number one goal is to improve and elevate the lives of neonates and children through state-of-the-art research.

We curently have 5 prospective studies and several retrospective studies including 2 drug studies, 2 equipment studies, one breast milk study and one focusing on children and diabetes. By bringing together a variety of perspectives and backgrounds, Coastal Children’s Services has developed an exceptional research program. Our team is constantly reviewing protocol and pushing forward to advance knowledge and solve the problems that impact the health of children in southeastern North Carolina.

Pediatric Research
Contributing to the development of treatments, drugs and devices specific to children is an important part of the Coastal Children’s Services mission. Children have often had to accept treatments and medications based on what is known to work in adults despite the fact that their metabolic pathways and organic functions differ widely. Even results from pediatric trials cannot be extrapolated to neonates. Neonates acquire conditions that occur exclusively in newborns, such as meconium aspiration syndrome and necrotizing enterocolitis. With that and the fact that off-label use is more rampant in newborns than in older children, pediatric and neonatal research are both priorities.

In addition to being a member of the Pediatric Clinical Trials Network, an alliance of clinical research sites cooperating in the design and conduct of pediatric clinical trials, Coastal Children’s Services also engages in pediatric research with independent sponsors and physicians to benefit the pediatric community at large.

Vision
To be a pioneer in the advancement of pediatric medicine through clinical research

Mission
To improve the lives of children by advancing evidence-based knowledge in pediatric care
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CURRENT STUDIES

OMM Study (Intiated June 2014 target end date 2021)

Title
Oropharyngeal Administration of Mother’s Colostrum: Health Outcomes of Premature Infants

Description
Own mother’s colostrum (OMC) and milk (OMM) help protect extremely premature infants (those born less than 1250 grams) against neonatal morbidity and mortality.  This study will evaluate the safety, efficacy and health outcomes of administering OMC/OMM directly inside the mouth of infants into the cheek cells.  Multiple centers are participating in this 5 year study and ultimately 622 patients will be enrolled from across all of the sites.  Our goal is to enroll 100 subjects from our NICU.  As of April 2016, we have enrolled 31 subjects.
Funding Source: Northshore University Health System Research Institute

DRAEGER STUDY (Initiated Jan 2016 target end date Dec 2016)

Title
A Clinical Study to Evaluate the Safety and Effectiveness of the Infinity Acute Care System Workstation Neonatal Care Babylog VN500 Device in High Frequency Oscillatory Ventilation (HFOV) Mode in Very Low Birth Weight (VLBW) Neonates


Description
Infants who are born between 23 - 30 weeks gestational age have a high risk of developing respiratory distress syndrome and often require mechanical breathing assistance from a ventilator.  The purpose of this study is to evaluate the use of a specific ventilator, the Infinity Acute Care System Workstation Neonatal Care Babylog VN400 in the High Frequency Oscillatory Ventilation (HFOV) mode (Babylog VN500 in HFOV mode, for short) to determine if it provides a more gentle ventilation system to very low birth weight infants.  The Babylog VN400 in HFOV mode has been available outside of the United States for the past few years.  However, the HFOV mode has not been approved by the Food and Drug Administration (FDA) and is considered experimental in the US.  The purpose of this study is to test the HFOV mode on the ventilator and compare results to retrospective data from similar babies treated with other FDA-approved HFOV devices during the last two years. The study results will be used to gain FDA approval for this investigational device.   The study is enrolling infants at many different locations and ultimately 225 infants will be enrolled.  Our goal is to enroll 20 babies from our NICU.  As of April 2016, we have enrolled 2 subjects.
Funding Source: Draeger Medical Systems


SCAMP STUDY

Title
Antibiotic Safety in Infants with Complicated  Intra-Abdominal Infections  Phase 2/3 Trial  

Description
The purpose of this study is to learn more about the safety of 4 different treatment regimens (combination of antibiotics) in infants with bacterial infections in the abdomen.   This study will help us to understand the proper dosage to use in infants and to help gain FDA approval to use these antibiotics for infections in the abdomen, specifically.  The study is enrolling infants at many different locations and ultimately 350 infants will be enrolled.  Our goal is to enroll 12 infants from our NICU.  As of April 2016, we have enrolled 5 subjects. 
Another part of this study will measure how much antibiotic reaches the central nervous system in infants by measuring the amount of antibiotic present in an infant’s cerebral spinal fluid and blood after they have received at least one dose of one of the antibiotics.  The study is enrolling 24 infants into this group with 3 infants from our NICU. 
Funding Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).


FUROSEMIDE STUDY (Initiated May 2016)

Title
Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD

Description
Infants who are born at less than 29 weeks gestational age are at greatly increased risk for developing a lung disease known as Bronchopulmonary Dysplasia or BPD.  BPD is the most common lung disease in preterm infants and is associated with life-long problems.  The purpose of this study to learn about the safety, potential side effects and dosing of a medicine called Furosemide (aka Lasix) when it is given to infants who are at risk for developing BPD.  The results of this study will help us find the safest and most helpful doses of furosemide to give to preterm infant to treat or prevent BPD.   The study is enrolling infants at many different locations and ultimately 120 infants will be enrolled.  Our goal is to enroll 12 infants from our NICU.  We will begin enrolling subjects in mid-May. 
Funding Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).


AEROSURF 1401

Description
Preterm infants lack a fluid in their lungs called surfactant which helps the lungs inflate more easily and reduces the work of breathing.   Without surfactant therapy, preterm infants are more likely to develop severe respiratory distress syndrome (RDS).  If preterm infants are displaying severe RDS, the surfactant is administered through a tube down their throat while they are receiving mechanical ventilation which could be injurious to the preterm infant’s lungs.  If preterm infants are only displaying mild to moderate RDS,  they are not given surfactant but instead are put on a less invasive oxygen support called nCPAP (nasal continuous positive airway pressure).  However, up to 1/2 of these infants will have their RDS worsen and will require the more invasive intubation so that surfactant can be administered.  This study will demonstrate the safety and efficacy of providing an aerosolized surfactant delivery system to infants while they are being supported by the less invasive nCPAP ventilation system.  The aerosolized surfactant will hopefully allow preterm infants to receive the surfactant earlier to prevent their RDS from worsening and avoid the injury caused by intubation.  We are not yet enrolling infants in this study, but our goal will be to enroll 10 from our NICU.
Funding source: Discovery Labs

Research Staff

donna Donna Vaught, PhD
Director of Research
Donna Vaught completed both her undergraduate and graduate school training at Virginia Polytechnic Institute & State University. She received her Ph.D. in Developmental Psychology in 1990 and completed a postdoctoral fellowship at the Kennedy Krieger Institute in 1991. Donna is NIDCAP trained and has been working with the NICU at NHRMC since September 1996. In addition to her duties at the hospital, Donna is a part-time instructor in the Department of Psychology at University of North Carolina - Wilmington.

Danielle Kurtz, RN, BSN
Research Coordinator
Danielle started the research department with Dr. Fernando Moya in 2011.  She currently serves as the research coordinator for several studies. She is the part-time lead for the Own Mother’s Milk (OMM) study that investigates a new way to orally administer colostrum to infants in the NICU who are receiving their mother’s own milk. She also oversees a retrospective chart review study investigating the use of caffeine citrate for the prevention of Apnea of Prematurity.  

Danielle attended Towson State University in Towson, Maryland where she received her BSN in Nursing in 1993. After working for over 10 years across the country as a Neonatal Intensive Care Nurse, a Pediatric Primary Care Nurse, and a Post-anesthesia Nurse, she joined New Hanover Regional Medical Center as a Neonatal Intensive Care Nurse in 2003. She then returned to Maryland to obtain her certification in the fundamentals of Research Coordination from Johns Hopkins in 2006. Returning to NHRMC, she became the Research Coordinator for SEAHEC Dept of Neonatology and then to CCNEO as Research Coordinator since 2011.

Her current research and project interests include Case-Control Genetic Study of Broncopulmonary Dysplasia and Validating the Accuracy of Weight Based Equations for Orogastric and Nasogastric Tube Placements in Neonates.

Arielle Lapid
Research Coordinator

Arielle Lapid works full-time as a research coordinator. She is instrumental in providing organization for all of our programs and facilitating the submission of the regulatory paperwork. She also manages the research interns who volunteer with our program.

Tiffony Blanks
Research Assistant
Tiffony completed her undergraduate degree at the University of Mount Olive. She received her Bachelor of Science degree in Business Administration and Health Care Management. Tiffony recently joined Coastal Carolina Neonatology's research team after 16 years with NHRMC, where she worked last in the NICU as a Patient Care Technician and ROP Coordinator. She is eager to learn more regarding research with neonates and excited to be a part of such a great team.

Christen Fergusen, NNP
Patient Consent
Works in the NICU and assists the team by obtaining patient consents for several ongoing studies.

Ashley Batten, NNP
Patient Consent
Works in the NICU and assists the team by obtaining patient consents for several ongoing studies.

Rachel Almond, PNP
Works in the Newborn Nursery and attends the weekly research meetings. She is EPIC-trained and supports the team with data extraction.

Daniel Moya
Research Support
Provides support for the research team

2014 POSTER PRESENTATION
Is Early Neonatal Hypophosphatemia Related to the Severity of Intrauterine Growth Restriction?
Presented by Fernando Moya, MD
Poster pdf
Original abstract doc

Peer-to-Peer Site Visits in a State Collaborative Model to Reduce Neonatal Central Line Associated Bloodstream Infections
Presented by Sheri Carroll, MD
Poster pdf
Original abstract doc

presented at
Pediatric Academic Societies, Vancouver, BC
The Pediatric Academic Societies (PAS) Annual Meeting is the largest international meeting focused on research in child health. We bring together a variety of groups to—not only discuss original research, which has been the hallmark of the PAS meet- ing, but to also discuss how this research can be applied to actual clinical practice in pediatrics. This alliance also provides opportunity to discuss other critical issues that affect child health such as public policy and advocacy. click for photos


2013 STUDIES

A Prospective Randomized Controlled trial Comparing the Accuracy of
a Weight-Based Method to the NRP Method for NGt/OGt insertion depth in Neonates.

Presented by Fernando Moya, MD
Poster pdf
Original abstract doc

presented at
Pediatric Academic Societies, Washington DC
The Pediatric Academic Societies (PAS) Annual Meeting is the largest international meeting focused on research in child health. We bring together a variety of groups to—not only discuss original research, which has been the hallmark of the PAS meet- ing, but to also discuss how this research can be applied to actual clinical practice in pediatrics. This alliance also provides opportunity to discuss other critical issues that affect child health such as public policy and advocacy. click for photos


2012 STUDIES
Evaluating the Accuracy of OGt/NGt Placement using the NRP Method
Presented by Fernando Moya, MD
Poster pdf
Original abstract doc

Presented by Fernando Moya, MD
Serum Hypophosphatemia in Growth Restricted and Appropriately Grown Preterm infants

Poster pdf
Original abstract doc

2011 STUDIES
Predicting the Correct Placement of Nasogastric (NGt) and Orogastric (OGt) tubes in Neonates
Presented by Fernando Moya, MD
Poster pdf
Original abstract doc

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Neonatal Care

Coastal Carolina Neonatology

Neonatal Intensive Care Unit (NICU)

Neonatal Transport

NICU Family Resources

NICU Follow-Up Clinic

Pediatrics

Pediatric Intensive Care Unit (PICU)

Pediatric Unit

Newborn Nursery

Nunnelee Pediatric Specialty Clinics

Resources

Betty H. Cameron Women's and
Children's Hospital

INFANTS

NHRMC

NHRMC Foundation

NICU Family Resources

SEAHEC

VON

2212 South 17th St. | Wilmington, NC 28401
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