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RecruitingNCT00747851Updated Dec 5, 2025

NETs: Protection or Harm in Neonatal Inflammation or Infection

An observational study in Necrotizing Enterocolitis (NEC), sponsored by University of Utah. Recruiting at 1 site in United States. Open to participants aged Up to 1 Hour, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by University of Utah · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Oct 2003; still recruiting 23 years 1 month later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
388
Ages
Up to 1 Hour
Sex
All
01

Study 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.

Read the detailed description

Many pediatric diseases including Systemic Inflammatory Response Syndrome (SIRS), sepsis, Acute Respiratory Distress Syndrome (ARDS) and neonatal Chronic Lung Disease (CLD) have been associated with dysregulation of the acute inflammatory response [1]. So it is with necrotizing enterocolitis (NEC). NEC, a disease of premature infants, afflicts 10% of very low birth weight infants. This disease is often fatal [2]. Less significant but nonetheless devastating sequelae include intestinal perforation, short gut syndrome, prolonged total parenteral nutrition with possible concomitant liver failure and a prolonged intensive care unit stay. The etiology remains unknown, although risk factors of prematurity, enteral feeds, infection and intestinal ischemia are associated with NEC [3].

The final common pathway for NEC appears, at least in part, to be mediated through the biologically active phospholipid platelet-activating factor (PAF). Each identified risk factor for NEC increases the serum levels of PAF in premature infants[4, 5]. Furthermore, serum levels of PAF-acetylhydrolase (PAF-AH), the enzyme responsible for catabolizing PAF, are lower in premature infants compared to term infants and lower in term infants compared to young children and adults [6, 7]. Although no clinical trials of PAF antagonists have been conducted in premature human infants, various PAF antagonists prevent NEC-like clinical disease in animal models [8-10].

Other data from animal models suggest a prominent role of the polymorphonuclear leukocyte (PMN) in the pathogenesis of NEC. Musemeche et al. induced NEC-like disease in rats by intra-aortic injection of PAF [11]. They used vinblastine, a chemotherapeutic agent with a side-effect profile significant for induction of neutropenia, to induce neutropenia in rats four days prior to intra-aortic injection of PAF. The vinblastine-induced neutropenia was protective for the clinical and pathologic manifestations of NEC-like disease. Other investigators have demonstrated an increase in PAF levels in the gastrointestinal tracts of rats subjected to gut ischemia/reperfusion. The elevated levels of intestinal PAF were then shown to chemo attract and prime PMNs [12].

The role of the human PMN in the acute inflammatory response is well documented. They play a fundamental role in the non-specific immune response and are rapidly recruited to areas of injury or inflammation where they participate in bacterial phagocytosis and killing. Disorders associated with a deficiency or impairment of PMNs (neutropenia, chronic granulomatous disease, leukocyte adhesion deficiency) predispose to infections with gram-negative and gram-positive bacteria [13]. However, regulation of this potent component of the acute inflammatory response is imperative. Disorders such as ARDS, ischemia/reperfusion injury and rheumatoid arthritis appear to result from the dysregulation of the PMNs' acute inflammatory response [1].

The molecular mechanisms regulating the PMNs' response in acute inflammation are not fully understood. In neutrophil priming, the activation of the NADPH oxidase enzyme via receptor-mediated stimulation with mediators such as fMLP or PAF is an increasingly complex process involving various cellular secondary messengers and the Rho family GTPase Rac2 [14, 15]. The mechanisms regulating PMN synthesis and release of pro-inflammatory cytokines such as IL-8 are less well understood. The mechanisms regulating PMN apoptosis are also not well understood. In vitro and in vivo studies indicate that the pro-inflammatory agents responsible for the priming of human PMNs also affect the longevity of those cells by delaying the PMNs in-built capacity to undergo apoptosis. In vitro studies on human PMNs show that pro-inflammatory mediators like Granulocyte/Macrophage - Colony Stimulating Factor (GM-CSF), Interleukin-8 (IL-8), Lipopolysaccharide (LPS), Complement 5a (C5a) and Interleukin-6 (IL-6) inhibit PMN apoptosis, while Tumor Necrosis Factor (TNF) and Fas-ligand (Fas-L) accelerate the rate of neutrophil apoptosis [16].

02

Conditions studied

  • Necrotizing Enterocolitis (NEC)

Keywords

  • protein
  • synthesis
  • response
  • PAF-stimulated
  • PMNs
  • collected
03

In context

Enterocolitis, Necrotizing

228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.

This study's planned enrollment of 388 is above the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.

Browse Enterocolitis, Necrotizing studies →

Lead sponsor

University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 1 Hour
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Infants with major congenital anomalies will be excluded.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
388 participants (estimated)
06

What researchers measure

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.

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2003 (actual). Primary completion is estimated for Apr 2026, 270 months after the start.

Of 39 observational studies under Enterocolitis, Necrotizing, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 115. This study's planned 270 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2008
First posted
Sep 5, 2008
StartActual
Oct 2003
Primary completionEst.
Apr 30, 2026
CompletionEst.
Apr 30, 2026
Last update
Dec 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00747851
Lead sponsor
University of Utah
Responsible party
Christian Con Yost (Principal Investigator, University of Utah) — Principal investigator
First posted
Sep 5, 2008
Start date
Oct 2003
Primary completion
Apr 30, 2026 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Dec 5, 2025

Study contacts

Christian C Yost, M.D.
Contact
christian.yost@hmbg.utah.edu
801/581-7052
Christian C Yost, M.D.
principal investigator · University of Utah

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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