- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01106209
Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Utah
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Salt Lake City, Utah, Stati Uniti, 84108
- University of Utah
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Salt Lake City, Utah, Stati Uniti, 84112
- Primary Children's Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion 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
- Infants admitted to the PCMC same-day surgery unit in preparation for elective surgery within the first year of life.
Exclusion Criteria:
- No other exclusion criteria
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
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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
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Healthy term infants
Term infants delivered at UUMC without complication, either via cesarean section or vaginal delivery
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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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Time to Maturation of Neutrophil Extracellular Trap(NET) Formation
Lasso di tempo: 5 years
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The objective is to characterize the time to maturation of NET formation capability in polymorphonuclear leukocytes(PMNs)isolated from newborn infants.
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5 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Determine Whether NETs Contribute to the Pathogenesis of Necrotizing Enterocolitis(NEC)
Lasso di tempo: 5 years
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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.
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5 years
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Christian C Yost, MD, University of Utah
Studiare le date dei record
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Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 119244
- R01HD093826 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .