Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes

NCT01106209 | Terminated Results

• 2 other identifiers: 119244R01HD093826
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to characterize the time to maturation of neutrophil extracellular trap(NET) formation capability in polymorphonuclear leukocytes(PMNs) isolated from newborn premature and term infants. Preterm infants who are enrolled into the study who then go on to require surgery \<1 year due to surgical NEC, will have the NET formation reassessed. This study will also determine whether NETs contribute to the pathogenesis of necrotizing enterocolitis (NEC). We hypothesize that NET formation contributes to the pathogenesis of NEC by inappropriately releasing degradative proteins and tissue destructive enzymes into the inflammatory milieu of the premature infant gastrointestinal tract following bacterial translocation. We also hypothesize that the delay in NEC development in premature infants (3rd - 4th week of life) as compared to at-risk term infants (1st week of life) results from a developmental delay in PMN ability to form NETs.

Conditions

Prematurity; Necrotizing Enterocolitis

Keywords

premature infants; polymorphonuclear leukocytes; PMNs; neutrophil extracellular traps; NET formation; necrotizing enterocolitis

Outcome Measures

Primary Outcomes (1)

• Time to Maturation of Neutrophil Extracellular Trap(NET) Formation

  The objective is to characterize the time to maturation of NET formation capability in polymorphonuclear leukocytes(PMNs)isolated from newborn infants.

  60 days

Study Arms (3)

Prematurely born infants in the NICU

Preterm infant patients delivered at UUMC and hospitalized in the NICU who are ≤1500 grams or \<30 weeks gestational age at birth.

Healthy term infants

Term infants delivered at UUMC without complication, either via cesarean section or vaginal delivery

Subset: Enrolled preterm infants having surgery at <1 year old for NEC

Enrolled preterm infants who require surgery for NEC within their first year of life for

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm and healthy term infants born at the University of Utah Hospital. A subset of preterm infants needing surgery \<1 year of age, will be reassessed.

You may qualify if:

• Preterm infant patients delivered at UUMC and hospitalized in the NICU who are ≤ 1500 grams or \<30 weeks gestational age at birth
• Term infants delivered at UUMC without complication, either via cesarean section or vaginal delivery

Sponsors & Collaborators

• University of Utah: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84112, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and intestinal tissue samples

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

This is an observational study designed to evaluate NEC incidence with in vitro assessment of neutrophil neutrophil extracellular trap formation. There are too few study participants to draw any meaningful correlations between in vitro NET formation by participant neutrophils and the incidence of NEC in this at-risk population.

Results Point of Contact

• Title: Christian Con Yost, MD
• Organization: University of Utah - Pediatrics

christian.yost@u2m2.utah.edu

801-518-7052

Study Officials

• Christian C Yost, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 19, 2010
• Study Start: April 1, 2010
• Primary Completion: June 22, 2020
• Study Completion: June 22, 2020
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2022-11

Locations

US (2)