NCT00747851 NETs: Protection or Harm in Neonatal Inflammation or Infection
| NCT ID | NCT00747851 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Necrotizing Enterocolitis (NEC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 388 participants |
| Start Date | 2003-10 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 388 participants in total. It began in 2003-10 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective in vitro cell biology study of polymorphonuclear leukocyte (PMN) protein synthesis in response to PAF. PMNs from cord blood of premature human infants at risk for NEC (birth weight between 501 - 1500 grams) and PMNs from cord blood of healthy term infants will be isolated and stimulated with PAF, a biologically active phospholipid implicated in the pathogenesis of NEC. NEC, a disease of prematurity with an incidence of 10.1% of infants born weighing between 501 - 1500 grams, is associated with significant morbidity and mortality. We will compare the protein synthesis of inflammatory modulators, including Interleukin 6 Receptor alpha (IL-6R alpha) and Retinoic Acid Receptor alpha (RAR alpha) proteins to protein synthesis responses already observed in PMNs isolated from healthy adults. Furthermore, we will characterize the expression and activity of the mammalian target of rapamycin (mTOR) translational protein synthesis control pathway in PMNs isolated from preterm and term infants and compare those results with previous observations in PMNs isolated from adults. This pathway is known to regulate IL-6R alpha and RAR alpha protein expression in PMNs isolated from adults. We will also follow those premature infants at risk for NEC clinically to determine which infants develop NEC and what risk factors may be associated with NEC in this population.
Eligibility Criteria
Inclusion Criteria: * Patients hospitalized in the NICU who were less than or equal to 1500 grams or less than 30 weeks gestational age at birth; Term infants delivered at UUMC without complication, either via cesarean section or vaginal delivery; Cord blood isolated within first hour of life; and parents or guardians must have signed informed consent. Exclusion Criteria: * Infants with major congenital anomalies will be excluded.
Contact & Investigator
Christian C Yost, M.D.
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT00747851 clinical trial?
This trial is open to participants of all sexes, up to 1 Hour, studying Necrotizing Enterocolitis (NEC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00747851 currently recruiting?
Yes, NCT00747851 is actively recruiting participants. Contact the research team at christian.yost@hmbg.utah.edu for enrollment information.
Where is the NCT00747851 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT00747851 clinical trial?
NCT00747851 is sponsored by University of Utah. The principal investigator is Christian C Yost, M.D. at University of Utah. The trial plans to enroll 388 participants.