Clinical trial Recruiting at 1 site Observational Ages Any age to 1 Hour

NETs — protective or harmful in newborn inflammation and infection?

Official title: NETs: Protection or Harm in Neonatal Inflammation or Infection

Run by University of Utah · NCT00747851 · Data updated 2026-11-12

We will test how immune cells from very premature babies at risk for NEC make proteins when exposed to a substance called PAF, comparing them with cells from healthy term infants and adults.

Quick facts

Study typeObservational
AgesAny age to 1 Hour
SexAll
Enrollment388 (estimated)
SponsorUniversity of Utah
Academic / other
Locations1 site (Salt Lake City, Utah)
StatusRecruiting
StartedOctober 2003
Main results expectedApril 30, 2026
Study endsApril 30, 2026
Registry record updatedDecember 5, 2025
Trial IDNCT00747851 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are infants born very preterm or very low birth weight (birth weight 501–1500 g or ≤30 weeks gestation) and healthy term infants whose cord blood can be collected within the first hour after delivery with parental consent.

Probably not a fit

Because this is an in vitro observational laboratory study, participating infants are unlikely to receive any direct medical benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective in vitro cell biology project that isolates polymorphonuclear leukocytes (PMNs) from cord blood of very low birth weight or very preterm infants and from healthy term infants. Collected PMNs are stimulated with platelet-activating factor (PAF) and examined for protein synthesis of inflammatory modulators such as IL-6Rα and RARα. The study also characterizes activity and expression of the mTOR translational control pathway in these neonatal PMNs and compares results to previously observed adult PMN responses. Cord blood is collected within the first hour of life and samples are analyzed in the laboratory without any clinical intervention on the infants.

Why it matters

Potential benefit: If successful, the findings could identify abnormal PMN protein-synthesis or mTOR signaling in preterm infants and suggest new targets to prevent or treat NEC.

How similar studies have gone: Animal models have shown that PAF antagonists can prevent NEC-like disease and adult PMN studies have characterized related protein responses, but applying these methods to PMNs from very preterm infants is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • University of Utah
    Salt Lake City, Utah, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.