Academic faculty members of the division of Neonatology at UCLA have collectively made a commitment to conduct clinical research under the auspices of the NRN multi-center trials. We will recruit adequate number of patients to generate necessary power to test stated hypotheses, thereby allowing valid conclusions about primary outcome measures. To compete for membership in the ongoing multi-center NICHD-NRN that sets the nation-wide """"""""gold standard"""""""" for clinical trials, we have 1] the necessary infrastructure in our UCLA """"""""Virtual NICHD-NRN type site"""""""" called the Neonatal Clinical Research Center (NCRC), 2] selected site PI and alternate PI with track records in conducting and participating in multi-center trials from a group of highly collaborative divisional faculty, 3] IRB approved comprehensive Neonatal Database, 4] HRIF clinic Program with >90% retention rate, 5] capability of long term follow-up with Developmental Pediatric faculty up to 8 years of age, 6] culture in UCLA-NICUs among multi-disciplinary ancillary staff of participating in clinical trials, 7] First line of defense for patient recruitment consisting of Neonatology fellows, NNPs, Clinical Research Nurse Specialists, and Neonatology Faculty who will identify eligible patients and implement study protocols 24/7 days a week, and 8] Experienced clinical research nurse coordinator, 9] Regular NCRC clinical trials/data analysis sessions that led to development of a concept application, """"""""Randomized Control Trial of Neuro-protection by Anti-Seizure Medications in HIE Neonates subjected to Hypothermia based on our existent research strengths in this field. This empowers us to propose the following specific aims:1] To participate with NRN under a cooperative agreement in an ongoing multi-center program designed to perform interventional and observational clinical studies in newborn babies, 2] To contribute to the steering committee of NRN ideas and discussions targeted at developing well designed clinical trials that can be implemented in NRN sites, and 3] To share data in a timely manner with the Centralized Data Coordinating Center and the DSMC, and contribute towards the final reporting of results along with development and data analyses of ancillary projects that may emerge from the NRN. UCLA's participation as a potential site will provide an exciting opportunity for us and we project that recruitment of patients with diverse ethnicity from the Los Angeles area will prove to be an important contribution to the NRN.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
1U10HD068270-01
Application #
8081377
Study Section
Special Emphasis Panel (ZHD1-DSR-A (03))
Program Officer
Higgins, Rosemary
Project Start
2011-04-01
Project End
2016-03-31
Budget Start
2011-04-01
Budget End
2012-03-31
Support Year
1
Fiscal Year
2011
Total Cost
$308,000
Indirect Cost
Name
University of California Los Angeles
Department
Pediatrics
Type
Schools of Medicine
DUNS #
092530369
City
Los Angeles
State
CA
Country
United States
Zip Code
90095
Bajaj, Monika; Natarajan, Girija; Shankaran, Seetha et al. (2018) Delivery Room Resuscitation and Short-Term Outcomes in Moderately Preterm Infants. J Pediatr 195:33-38.e2
Chawla, Sanjay; Natarajan, Girija; Chowdhury, Dhuly et al. (2018) Neonatal Morbidities among Moderately Preterm Infants with and without Exposure to Antenatal Corticosteroids. Am J Perinatol 35:1213-1221
Brumbaugh, Jane E; Colaizy, Tarah T; Saha, Shampa et al. (2018) Oral feeding practices and discharge timing for moderately preterm infants. Early Hum Dev 120:46-52
Natarajan, Girija; Shankaran, Seetha; Saha, Shampa et al. (2018) Antecedents and Outcomes of Abnormal Cranial Imaging in Moderately Preterm Infants. J Pediatr 195:66-72.e3
Meyers, J M; Tan, S; Bell, E F et al. (2018) Neurodevelopmental outcomes among extremely premature infants with linear growth restriction. J Perinatol :
Watterberg, K L; Fernandez, E; Walsh, M C et al. (2017) Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants. J Perinatol 37:1220-1223
Puopolo, Karen M; Mukhopadhyay, Sagori; Hansen, Nellie I et al. (2017) Identification of Extremely Premature Infants at Low Risk for Early-Onset Sepsis. Pediatrics 140:
James, Jennifer; Munson, David; DeMauro, Sara B et al. (2017) Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support. J Pediatr 190:118-123.e4
Peralta-Carcelen, Myriam; Carlo, Waldemar A; Pappas, Athina et al. (2017) Behavioral Problems and Socioemotional Competence at 18 to 22 Months of Extremely Premature Children. Pediatrics 139:
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628

Showing the most recent 10 out of 20 publications