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Observational Study of NEC in Premature Infants

This study is looking at how certain immune cells (polymorphonuclear leukocytes or PMNs) from newborn babies respond to a substance called PAF (platelet-activating factor). PAF is thought to play a role in Necrotizing Enterocolitis (NEC), a serious gut condition that affects premature infants. Researchers will collect cord blood from premature babies at risk for NEC and from healthy full-term babies. They will then study how the PMN cells in this blood produce inflammatory proteins like Interleukin 6 Receptor alpha (IL-6R alpha) and Retinoic Acid Receptor alpha (RAR alpha) when exposed to PAF. The main goal is to understand if these responses are linked to whether premature infants develop NEC and how they fare up to two years of age. This is an observational study, meaning no interventions are given.

Study design
This is an observational study looking at 388 participants. It is not a treatment study, but rather aims to understand how certain cells behave.
What's involved
Cord blood will be collected within the first hour of life. Parents or guardians will need to sign an informed consent form.
Compensation
Not stated in the trial record.
Follow-up
The incidence and survival of premature infants with NEC will be measured at 2 years.

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NCT00747851

NETs: Protection or Harm in Neonatal Inflammation or Infection

Recruiting
Not specifiedUp to 1Observational
University of Utah
~388 participants
Updated 2025-12-05 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 2 years

Conditions

Necrotizing Enterocolitis (NEC)

Explore related trials

Necrotizing Enterocolitis

Where it's being run

1 sites across 1 states
Utah1

Study leadership

  • Christian C Yost, M.D. · PRINCIPAL_INVESTIGATOR · University of Utah

Who to contact

Christian C Yost, M.D.
[email protected]
801/581-7052
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Eligibility criteria

Inclusion

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

Infants with major congenital anomalies will be excluded.

What this trial measures

  • 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