Clinical Investigations

Clinical Center for Neonatal and Childhood Research

Our multidisciplinary research team includes research coordinators, assistants/associates, nurses, dietitians, and a database team.  We are located at University Hospital in San Antonio, Texas. We are part of the Vermont Oxford Network.

We conduct clinical trials in many areas including neonatal lung disease, neonatal nutrition, neonatal neurodevelopment, neonatal infectious disease, pediatric endocrinology, pediatric pulmonary/CF, pediatric gastroenterology, pediatric ophthalmology/retina, pediatric allergy-immunology, pediatric cardiology, and child abuse.

We currently have eighty-seven open clinical research studies/clinical trials in the Department of Pediatrics. Of those, 27% are led by the Neonatology Division.

Neonatal Infectious Diseases, (JB Cantey)

Antimicrobial Stewardship Support in South Texas (ASSIST) Program:

  • Designed to deliver antimicrobial stewardship support to rural or medically underserved nurseries
  • The ASSIST-1 trial demonstrated safe and effective reduction in antibiotic use for infants in the well-baby or intermediate care nurseries in South Texas.
  • ASSIST-2 is aimed at disseminating and implementing the program throughout all of rural Texas.
  • The proposed ASSIST-3 trial is intended to study the dissemination of the program to remote states with large rural networks, such as Montana or Alaska.
  • ·NICU Antibiotics and Outcomes (NANO) Trial:
  • Goal is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birth weight infants in the first days of life.
  •  802-subject, multi-center, placebo-controlled, randomized clinical trial
  • Hypothesis: the incidence of adverse outcomes is higher in babies receiving empiric antibiotics in the first week of life compared to babies receiving placebo.
  • Primary outcomes: composite of late-onset sepsis, necrotizing enterocolitis, or death during the index hospitalization.
  • Site principal investigator

RSV Vaccine for Pregnant Women:

  • Phase 3, randomized double-blinded, placebo-controlled trial to evaluate the efficacy and safety of an RSV subunit vaccine in infants born to women vaccinated during pregnancy
  • Site co-investigator (primary investigator for pediatrics)

Pertinent Publications:

1.     Short-Term Complications Associated with Surgical Ligation of Patent Ductus Arteriosus in ELBW Infants: A 25-Year Cohort Study.  Foster M, Mallett LH, Govande V, Vora N, Castro A, Raju M, Cantey JB. Am J Perinatol. 38(5):477-481, 2021.

2.     C-Reactive Protein Testing in Late-Onset Neonatal Sepsis: Hazardous Waste. Cantey, J. B. & Bultmann, C. R. JAMA Pediatrics. 174, 3, 235-236 2, 2020.

3.     Neonatal-Perinatal Infections: An Update. Cantey JB, Shane AL. Clin Perinatol. 48(2). doi: 10.1016/j.clp.2021.03.014. 2021.

4.     Biomarkers for the Diagnosis of Neonatal Sepsis.  Cantey JB, Lee JH. Clin Perinatol. 48(2):215-227. doi: 10.1016/j.clp.2021.03.012. 2021.

5.     Antibiotic exposure and growth patterns in preterm, very low birth weight infants.  Pyle AK, Cantey JB, Brown LS, Heyne RJ, Wozniak PS, Heyne E, Holcombe A, Brammer EM, Lair CS, Sánchez PJ.  Matern Health Neonatol Perinatol. 29;7(1):7. doi: 10.1186/s40748-021-00126-6. 2021

6.     Early Antibiotic Therapy and Adverse Outcomes in Preterm Infants: Time for a Trial!  Cantey JB. 227:13-14. doi: 10.1016/j.jpeds.2020.07.046. 2020

7.     Malassezia Hepatic Abscess in a Neonate. Cantey JB, Dallas SD, Cigarroa FG, Quinn AF.  Pediatr Infect Dis J. 39(11):1043-1044. doi: 10.1097/INF.0000000000002789. 2020

8.     Antibiotic resistance in the neonatal intensive care unit. Ramirez, C. B. & Cantey, J. B. NeoReviews. 20, 3, p. e135-e144, 2019

Neonatal Nutrition and Bone Institute (NNBI) (CL Blanco, AG Moreira, AK Gong, DC McCurnin, E Brownell , J McGrath)

This is a Premiere Center for the Healthy Development of Neonates. Our team of experts includes neonatologists, dieticians, gastroenterologists, neonatal pharmacists, NICU nurses, hospitalists, physical therapists, occupational therapists, speech language pathologists, social workers and psychologists.

 Current Trials and Observational Investigations:

  • Short gut/bowel syndrome, gastroschisis, duodenal, jejunal or ileal atresia, intestinal dysmotility through the intestinal/liver failure program
  • Parenteral Nutrition Associated Cholestasis (PNAC) and novel approaches
  • Feeding difficulty and poor growth with body composition outcome analyses
  • Necrotizing enterocolitis and novel therapeutic approach
  • Extreme prematurity and metabolic bone disease
  • Iron overload in ECMO Patients
  • Genetic disparities and early effects of intrauterine environmental exposures

What the NNBI Offers:

  •  An individual health plan designed to meet the neonate’s specific needs
  •  Diagnostic testing, such as body composition, bone mineral density and bone strength with DXA scan and air displacement plethysmography
  •  Diagnostic studies, such as endoscopy, colonoscopy and biopsy
  •  Clinical research trials
  •  Donor breast milk program

Pertinent Publications:

1.     Cycled Phototherapy Dose-Finding Study for Extremely Low-Birth-Weight Infants: A Randomized Clinical Trial.  Arnold C, Tyson JE, Pedroza C, Carlo WA, Stevenson DK, Wong R, Dempsey A, Khan A, Fonseca R, Wyckoff M, Moreira A, Lasky R. JAMA Pediatr. 174(7):649-656. doi: 10.1001/jamapediatrics.2020.0559. 2020.

2.     Extracorporeal Life Support in Pediatric Patients with Bronchopulmonary Dysplasia and Associated Pulmonary Hypertension. AP. Hernandez, NR. Carr, D. McCurnin, V. Armijo-Garcia. ASAIO Journal, 2020

3.     Maternal diabetes and obesity influence the fetal epigenome in a largely Hispanic population. Rizzo HE, Escaname EN, Alana NB, Lavender E, Gelfond J, Fernandez R, Hibbs MA, King JM, Carr NR, Blanco CL. Clin Epigenetics.;12(1):34. doi: 10.1186/s13148-020-0824-9. 2020

4.     Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight. Hair AB; Blanco CL; Moreira AG; Hawthorne KM; Lee ML; Rechtman DJ; Abrams SA.  Journal of Pediatrics. 165(5):915-20, 2014

5.     Premature Infants 750-1,250 g Birth Weight Supplemented with a Novel Human Milk-Derived Cream Are Discharged Sooner. Hair AB, Bergner EM, Lee ML, Moreira AG, Hawthorne KM, Rechtman DJ, Abrams SA, Blanco CL. Breastfeed Med.:133-7. doi: 10.1089/bfm.2015.0166. 2016

6.     Abnormal bone mineral content and density in people with tetrasomy 18p. Moreira, A., Das, H., Hasi-Zogaj, M., Soileau, B., Hill, A., Bruder, J. M., Hale, D. E. & Cody, J. D.  American Journal of Medical Genetics, Part A. 179, 3, p. 417-422 6 p. 2019

7.     Favorable Outcomes of Preterm Infants with Parenteral Nutrition-associated Liver Disease Treated with Intravenous Fish Oil-based Lipid Emulsion. Sorrell, M., Moreira, A., Green, K., Jacob, R., Tragus, R., Keller, L., Quinn, A., McCurnin, D., Gong, A., El Sakka, A., Mittal, N. & Blanco, C . Journal of Pediatric Gastroenterology and Nutrition. 64, 5, p. 783-788 6 p. 2017

8.     Metabolic bone disease of prematurity. Moreira, A. G., Jacob, R., Lavender, L. & Escaname, E. NeoReviews. 16, 11, p. e631-e641, 2015

Neonatal Newborn Follow-up, Screening, Breastfeeding Initiative (AK Gong, AR Quinn, AG Moreira)

Family Nurture Invention:

  • Randomized controlled trial with families learning to co-regulate with their infant versus control to see effect on brain wave development at term equivalent using 132 lead EEG
  • Developmental anomalies associated with oral feeding
  • Retinopathy of prematurity
  • Early cerebral Palsy (CP) diagnosis

Pertinent Publications:

1.     80 Years of vision: preventing blindness from retinopathy of prematurity. Wood EH, Chang EY, Beck K, Hadfield BR, Quinn AR, Harper CA. J Perinatol. 41(6):1216-1224. doi: 10.1038/s41372-021-01015-8. 2021

2.     Clinical practice guidelines on newborn hearing screening: A systematic quality appraisal using the AGREE II instrument.  Chorath K, Garza L, Tarriela A, Luu N, Rajasekaran K, Moreira A.  Int J Pediatr Otorhinolaryngol. 141:110504. doi: 10.1016/j.ijporl.2020.110504. 2021

3.     Factors in Premature Infants Associated with Low Risk of Developing Retinopathy of Prematurity. Wade KC, Ying GS, Baumritter A, Gong AK, Kemper AR, Quinn GE, eROP Cooperative Group.  JAMA Ophthalmology, 137(2):160-166. 2018

4.     Texas Pulse Oximetry Project: A Multicenter Educational and Quality Improvement Project for Implementation of Critical Congenital Heart Disease Screening Using Pulse Oximetry.  Guillory C, Gong AK. Livingston J, Creel L, OCampo E, McGee-Garrett T. Am J Perinatol, 34(9):856-860. 2017

5.     A Multicenter Initiative for Critical Congenital Heart Disease Newborn Screening in Texas Neonatal Intensive Care Units. Gong AK, Guillory C, Creel L, Livingston JE, McKee-Garrett TM, Fortunov R. Am J Perinatol, 34(9):839-844. 2017

6.     Changes in Course of Retinopathy of Prematurity from 1986 to 2013: Comparison of Three Studies in the United States Opthalmology, Quinn GE, Barr C, Bremer D, Fellows R, Gong A, Hoffman R, Repka MX, Shepard J, Siatkowski RM, Wade K, Ying G. 123:1-6. 2016

7.     Newborn intensive care survivors: a review and a plan for collaboration in Texas Maternal Health, Gong AK, Johnson Y, Livingston J, Matula K, Duncan A. Neonatology and Perinatology 2015