An observational study in Prematurity and Necrotizing Enterocolitis, sponsored by University of Utah. Terminated at 2 sites in United States. Open to participants aged Up to 1 Year, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by University of Utah · Observational
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.
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.
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This study's enrollment of 14 is below the median of 120 across 806 observational studies indexed under Premature Birth.
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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.
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Exclusion Criteria:
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
Enrolled preterm infants who require surgery for NEC within their first year of life for
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.
Time frame: 60 days
| Milestone | Prematurely Born Infants in the NICU | Healthy Term Infants | Infants Having Surgery at <1 Year Old |
|---|---|---|---|
| Started | 11 | 3 | 0 |
| Completed | 11 | 3 | 0 |
| Not completed | 0 | 0 | 0 |
The objective is to characterize the time to maturation of NET formation capability in polymorphonuclear leukocytes(PMNs)isolated from newborn infants.
| Days | Prematurely Born Infants in the NICU | Healthy Term Infants | Infants Having Surgery at <1 Year Old |
|---|---|---|---|
| Time to Maturation of Neutrophil Extracellular Trap(NET) Formation | 14 (3 to 17) | 5 (4 to 14) | — |
Collected over First 2 months of life.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prematurely Born Infants in the NICU | 1/11 (9.1%) | 0/11 (0%) | 0/11 (0%) |
| Healthy Term Infants | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Infants Having Surgery at <1 Year Old | — | — | — |
None of our recruited prematurely born infants in the NICU required surgery in the first year of life.
| Age, Categorical(Participants) | Prematurely Born Infants in the NICU | Healthy Term Infants | Subset: Enrolled Preterm Infants Having Surgery at <1 Year Old | Total |
|---|---|---|---|---|
| <=18 years | 11 | 3 | 0 | 14 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(Day) | Prematurely Born Infants in the NICU | Healthy Term Infants | Subset: Enrolled Preterm Infants Having Surgery at <1 Year Old | Total |
|---|---|---|---|---|
| Mean | 1 (1 to 1) | 1 (1 to 1) | — | 1 (1 to 1) |
| Sex: Female, Male(Participants) | Prematurely Born Infants in the NICU | Healthy Term Infants | Subset: Enrolled Preterm Infants Having Surgery at <1 Year Old | Total |
|---|---|---|---|---|
| Female | 6 | 1 | — | 7 |
| Male | 5 | 2 | — | 7 |
| Ethnicity (NIH/OMB)(Participants) | Prematurely Born Infants in the NICU | Healthy Term Infants | Subset: Enrolled Preterm Infants Having Surgery at <1 Year Old | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 0 | — | 2 |
| Not Hispanic or Latino | 9 | 3 | — | 12 |
| Unknown or Not Reported | 0 | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | Prematurely Born Infants in the NICU | Healthy Term Infants | Subset: Enrolled Preterm Infants Having Surgery at <1 Year Old | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | — | 0 |
| Asian | 0 | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | — | 0 |
| Black or African American | 0 | 0 | — | 0 |
| White | 11 | 3 | — | 14 |
| More than one race | 0 | 0 | — | 0 |
| Unknown or Not Reported | 0 | 0 | — | 0 |
| Region of Enrollment(participants) | Prematurely Born Infants in the NICU | Healthy Term Infants | Subset: Enrolled Preterm Infants Having Surgery at <1 Year Old | Total |
|---|---|---|---|---|
| United States | 11 | 3 | — | 14 |
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This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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