NETs: Protection or Harm in Neonatal Inflammation or Infection

NCT00747851 | Recruiting

• 2 other identifiers: 11919R01HD093826
• Study Type: observational
• Target: 388
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Multiple morbidities and other clinical data will be collected and evaluated with respect to NEC and PMN protein analysis

  2 years

Eligibility Criteria

• Age: Up to 1 Hour
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in the NICU who were less than or equal to 1500 grams or less than 30 weeks gestational age at birth

You may qualify if:

• 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.

You may not qualify if:

• Infants with major congenital anomalies will be excluded.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Christian C Yost, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian C Yost, M.D.

CONTACT

801/581-7052; christian.yost@hmbg.utah.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 5, 2008
• Study Start: October 1, 2003
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)