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Clinical Trial Summary

Despite a greater understanding of NEC physiopathology, modest progress has been done in terms of intervention and prevention of the disease over the past three decades, being the mortality rate unchanged.

Investigators intend to leverage our knowledge and technical expertise developed with fetal enteroids to further investigate the processes leading to NEC by deriving and performing functional studies on human intestinal enteroids generated from intestinal resection for therapeutic reasons in NEC and non-NEC patients

1. Generate a tissue biorepository composed of: enteroids and other lamina propria cells

2. Comparative studies of the gene expression profile of tissue, epithelial enteroids and underlying lamina propria of NEC, non-NEC, hypoxic and non-hypoxic infants

3. In vitro functional studies for the evaluation of critical factors in NEC pathophysiology

4. In vitro functional studies to identify the activation of processes leading to intestinal epithelium necroptosis and/or apoptosis in bacteria challenged and hypoxic conditions

5. Correlative studies of the impact of perinatal variables on the intestinal barrier functionality at baseline and challenged with pathogens

6. In vitro comparison of the intestinal barrier functionality in infants complicated by condition of prenatal hypoxia versus non hypoxic infants

7. Validation the NEC enteroids as an in vitro model for the identification of treatments and prevention of NEC

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT04549727
Study type Observational
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Paola Roggero, MD PHD
Phone +393472777054
Status Not yet recruiting
Start date November 1, 2020
Completion date February 17, 2022

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