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:
An adaptive clinical trial of BeginNGS newborn screening for hundreds of genetic diseases by genome sequencing | PI: Karen Mestan
Social Media and Risk-reduction Training for Preterm Infant Care Practices Study (SMART PREEMIE) | PI: Henry Lee
Supraglottic Airway for Resuscitation Trial (SUGAR) | PI: Pamela Del Rosario
Inhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) – The “NoNO Trial” - a multi-center, de-implementation, stepped-wedge, cluster-randomized trial within an established collaborative | PI: Denise Suttner
Assessing Caregiver Perception of Dicharge Readiness | PI: Henry Lee
Genotypic and phenotypic characterization of pathogenic neonatal Escherichia coli strains | PI: Eniko Sajti
Congenital Diaphragmatic Hernia Study Group (CDHSG) | PI: Jeanne Carroll
Diaphragmatic Hernia Research and Exploration; Advancing Molecular Science (DHREAMS) | PI: David McCulley
Delivery Room Intervention and Evaluation Registry (DRIVE) | PI: Pamela Del Rosario
NICU Interest Group Survey | PI: David McCulley
The Impact of Opioids on Health Outcomes for Hospitalized Infants | PI: Henry Lee
Demographic disparities in breastfeeding outcomes in San Diego County Utilizing NICU/Newborn Discharge Databases | PI: Katherine Weiss
The Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset | PI: Katherine Weiss
Health Equity in the NICU | PI: Katherine Nyman
NeoBeat: Heart rate assessment during and after delayed cord clamping using a portable non-wired electrocardiographic device | PI: Henry Lee
Positive End-Expiratory Pressure Levels during Resuscitation of Preterm Infants at Birth (The POLAR Trial) | PI: Sandra Leibel
Improving outcomes of periviable births via an enhanced prediction tool | PI: Henry Lee
A Phase 2, Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns with Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia with Long-Term Follow-Up (STAR) | PI: Jeanne Carroll
Factors that Affect Breastfeeding Pre-term and Term Infants During and After Admission to a Level III NICU | PI: Sandra Leibel
Parental Voice in Shared Decision Making: Evaluating the experience of parents with children with Trisomy 18 or 13 | PI: Krishelle Marc-Aurele
DOXIE: Delayed Cord Clamping with Oxygen in Extremely Low Gestational Age Infants | PI: Henry Lee
NeoBANK: Neonatal Biorepository Advancing the NICU Knowledgebase | PI: Karen Mestan
Analysis of Human Lung Samples to Identify Inflammatory Markers Associated with Disease Severity | PI: Eniko Sajti
Advancing NICU family engagement through legal assistance and advocacy | PI: Henry Lee
“Flow and Grow” – The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants | PI: Sandra Leibel
The Role of TREM2 in Obesity-Associated Immune Maladaptation during Pregnancy | PI: Eniko Sajti
Neonatal Outcomes Database | PI: Karen Mestan
UCSD Pediatric Resident Intubation Experience | PI: Charlie Sauer
Using Electrical Impedance Tomography (EIT) Technology to Determine the Cause of Significant Events in the Preterm Neonate | PI: Sandra Leibel
UCSD/RCHSD Neonatal-Perinatal COVID-19 Database | PI: Karen Mestan
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
Prospective Review of Extracorporeal Membrane Oxygenation (ECMO) Treatment, Complications, and Outcomes | 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):
NeoLev3: A Phase IIB Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures of Mild to Moderate Severity | PI: Jeff Gold (Neurology)
Retrospective and prospective data collection of maternal, fetal, and neonatal variables from patients referred to the UC Fetal Consortium with a pregnancy complication or carrying a fetus with a congenital anomaly | PI: Louise Laurent (MFM)
"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 | https://mommysmilkresearch.org/