Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes
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|ClinicalTrials.gov Identifier: NCT01106209|
Recruitment Status : Suspended (Seeking further funding)
First Posted : April 19, 2010
Last Update Posted : February 5, 2020
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|Condition or disease|
|Prematurity Necrotizing Enterocolitis|
Prematurely born infants are at risk for necrotizing enterocolitis (NEC), the most common gastrointestinal emergency encountered in the newborn intensive care unit. This disease occurs in between 5 - 10% of infants born at less than 30 weeks gestation or less than 1500 grams birth weight. In these patients, NEC routinely develops during the 3rd or 4th week of life. NEC rarely occurs in infants born closer to term; for these patients NEC usually develops during the 1st week of life. So far, no one has explained the inverse relationship between gestational age at birth and the delay in NEC development.
Recently, our laboratory described for the first time an inherent deficiency of innate immunity in newborn infants - failure of neutrophil extracellular trap formation. Neutrophil extracellular traps or NETs are complex lattices of extracellular chromatin and DNA decorated with anti-microbial proteins and degradative enzymes which trap and kill microbes. When the neutrophils of newborn infants develop the ability to form NETs and whether the maturation of NET formation correlates with development of NEC in at risk infants remains unknown.
We have therefore undertaken the following study best described as a prospective, in vitro longitudinal cellular biology study of LPS/PAF-stimulated PMNs isolated from the cord and peripheral blood of premature infants at risk for NEC and from term infants not considered at risk for NEC. We will also assay for NET formation in gastrointestinal tissue samples obtained at the time of surgery for severe NEC in enrolled prematurely born infants. These studies are the first of their kind and aim to answer these important questions.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||March 31, 2023|
|Estimated Study Completion Date :||March 31, 2023|
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
Infants having surgery at <1 year old
Infants admitted to the PCMC same-day surgery unit in preparation for elective surgery within the first year of life
- Time to Maturation of Neutrophil Extracellular Trap(NET) Formation [ Time Frame: 5 years ]The objective is to characterize the time to maturation of NET formation capability in polymorphonuclear leukocytes(PMNs)isolated from newborn infants.
- Determine Whether NETs Contribute to the Pathogenesis of Necrotizing Enterocolitis(NEC) [ Time Frame: 5 years ]The purpose is to determine if 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.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||up to 1 Year (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- 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
- Infants admitted to the PCMC same-day surgery unit in preparation for elective surgery within the first year of life.
- No other exclusion criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106209
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84108|
|Primary Children's Medical Center|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Christian C Yost, MD||University of Utah|
|Responsible Party:||Christian Yost, Principal Investigator, University of Utah|
|Other Study ID Numbers:||
R01HD093826 ( U.S. NIH Grant/Contract )
|First Posted:||April 19, 2010 Key Record Dates|
|Last Update Posted:||February 5, 2020|
|Last Verified:||February 2020|
neutrophil extracellular traps
Digestive System Diseases