Actively Recruiting
NETs: Protection or Harm in Neonatal Inflammation or Infection
Led by University of Utah · Updated on 2025-12-05
388
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how certain immune cells called polymorphonuclear leukocytes (PMNs) from premature infants at risk for necrotizing enterocolitis (NEC) respond to a molecule called platelet-activating factor (PAF). NEC is a serious disease affecting about 10% of very low birth weight premature infants, often leading to severe complications or death. This observational study also compares protein synthesis and inflammatory responses in PMNs from premature and healthy term infants, and relates findings to previous data from adults. The study collects cord blood samples from premature infants weighing between 501 and 1500 grams and from healthy term infants shortly after birth. PMNs are isolated and stimulated with PAF to examine protein production, including inflammatory modulators like Interleukin 6 Receptor alpha and Retinoic Acid Receptor alpha. The activity of a protein control pathway called mTOR is also studied in these cells. Researchers follow the premature infants clinically over two years to identify which develop NEC and investigate associated risk factors. Participants are hospitalized newborns in the neonatal intensive care unit (NICU) meeting weight or gestational age criteria, along with healthy term infants. Cord blood is collected within the first hour of life. Clinical data and multiple health outcomes are tracked for two years, focusing on NEC incidence and survival as the main outcome. The study also gathers information on other medical conditions and protein analyses related to NEC. Safety and long-term monitoring occur through this observation period lasting up to two years.
CONDITIONS
Brief Title
NETs: Protection or Harm in Neonatal Inflammation or Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Parents or guardians must have signed informed consent
You will not qualify if you...
- Infants with major congenital anomalies will be excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants who undergo routine neonatal intensive care are observed with collection of clinical data and analysis of blood samples to study inflammation and infection.
Ongoing clinical monitoring during NICU stay and follow-up visits as scheduled by treating physicians
Trial Site Locations
Total: 1 location
1
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
C
Christian C Yost, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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