NETs — protective or harmful in newborn inflammation and infection?
NETs: Protection or Harm in Neonatal Inflammation or Infection
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 type | Observational |
|---|---|
| Enrollment | 388 (estimated) |
| Ages | N/A to 1 Hour |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT00747851 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Because this is an in vitro observational laboratory study, participating infants are unlikely to receive any direct medical benefit from participation.
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 performed: 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.
Eligibility criteria
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 this trial is running
Salt Lake City, Utah
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Christian C Yost, M.D. — University of Utah
- Study coordinator: Christian C Yost, M.D.
- Email: christian.yost@hmbg.utah.edu
- Phone: 801/581-7052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.