Ongoing Clinical Research

One of the primary goals of our division and the shared vision of all our faculty and staff is to provide better care, health, and outcomes for infants. To promote this goal, we support a range of investigator initiated and sponsor initiated research focused on improving health for infants today and tomorrow.  This research includes everything from case studies and chart reviews to multicenter, interdisciplinary clinical trials.  

From bench to bedside, around the world and back, our research has included both internal and external collaborators.  Internal collaborators have included bioengineering, cardiology, genomics, infectious disease, neurology, ophthalmology, and more.  On a national and international level, we have been involved in clinical trials on IV Tylenol, cooling on transport, levetiracetam (an anti-seizure medication), IV nutrition, antibiotic safety, and more.  Funding for our projects has come from the NIH, NICHD, the Thrasher Foundation, the Rady Children’s Hospital Foundation, and various industry sponsors among others.

Our current division projects include the following:

UCSD/RCHSD Neonatal-Perinatal COVID-19 Database | PI: Karen Mestan

Safety of Sildenafil in Premature Infants with Severe Bronchopulmonary Dysplasia | PI: Jeanne Carroll

Pilot Study: Evaluating the feasibility of role playing for fellows to practice skills for giving serious news using a virtual platform | PI: Krishelle Marc-Aurele

Neonatal Outcomes of Patients in the UCSD Obstetric Registry | PI: Sandra Leibel

Microbiome and Metabolome in Neonates with Gastroschisis: A University of California Fetal Consortium Study | PI: Sandra Leibel

Prospective Review of Extracorporeal Membrane Oxygenation (ECMO) Treatment, Complications, and Outcomes | PI: Denise Suttner

Study of Attitudes and Factors Effecting PREterm infant care Practices (SAFE PREP) – Phase II | PI:  Karen Mestan

National Registry for Surveillance and Epidemiology of Perinatal COVID-19 Infection | PI: Laurel Moyer

Interviewing Spanish Speaking Parents about Communication in the NICU | PI: Krishelle Marc-Aurele

TIME Study: A Randomized Controlled Trial of Therapeutic Hypothermia for Infants with Mild Encephalopathy in California | PI: Jose Honold

Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle Congenital Heart Disease (Multicenter study with the NICHD Pediatric Trials Network / Duke Clinical Research Institute) | PI: Denise Suttner

Utilizing scavenged complete blood count samples for NeoChip testing and validation  | PI: Eniko Sajti (Collaboration with bioengineering)

NeoChip: High Resolution Melt with machine learning for the accurate and rapid diagnosis of sepsis in neonates (Collaboration with bioengineering) | PI: Eniko Sajti

Additionally, the following projects are collaborations with other divisions, currently recruiting/enrolling in the UCSD and RCHSD NICU(s):

"LENS" - A Multicenter, Open-label, Randomized, Active Comparator Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates with Repeated Electroencephalographic Neonatal Seizures | PI:  Jeff Gold (Neurology)

"PROPER": Partnership for retinopathy of prematurity evaluation in the real world (PROPER) consortium | PI: Eric Nudleman (Ophthalmology) 

A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia with Distal Tracheoesophageal Fistula Repair | PI: David Lazar (Surgery)

A simple method of detecting neurologic disease in the neonate and young child | PI: Jeff Gold (Neurology)

"CAZ-AVI": A Phase 2A, 2-Part, Open-Label, Non-randomized, multicenter, single and multiple dose trial to evaluate pharmacokinetics, safety and tolerability of ceftazidime and avibactam in neonates and infants from birth to less than 3 months of age with suspected or confirmed infections due to gram-negative pathogens requiring intravenous antibiotic treatment | PI: John Bradley (Infectious Disease)

"MAP": The Association Between Milk Feedings in the Preterm Population, the Microbiome, and the Risk of Atopic Disease | PI: Sydney Leibel (Allergy & Immunology), Co-I: Sandra Leibel

Mommy’s Milk – Human Milk Biorepository |

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