Recruiting

PAF

Sponsor:

University of Utah

Code:

NCT00747851

Conditions

Necrotizing Enterocolitis (NEC)

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Necrotizing Enterocolitis (NEC)

Study ID

NCT00747851

Start date

Oct, 2003

Status verified date

Dec, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

388 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • The incidence and survival of premature infants with NEC, defined prospectively as disease meeting criteria for Bell's classification category IIA or greater [See Table 1] as applied by the subject's attending physician. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Principal Investigator:

Christian C Yost, M.D.

More Information

Sponsor

University of Utah

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Keywords

  • protein
  • synthesis
  • response
  • PAF-stimulated
  • PMNs
  • collected

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-12-05.