Development and Use of a Tissue and Human Enteroid Biorepository to Study the Pathophysiology of NEC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-02-17

Brief Summary

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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

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Detailed Description

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Conditions

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Enterocolitis, Necrotizing Prematurity Gastrointestinal Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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infants with surgical NEC

Infants who undergo surgery for NEC disease

Organoids creation

Intervention Type OTHER

Organoids are created from discarded tissue

Infants with GI surgical diseases other than NEC

Infants who undergo surgery for other GI diseases than NEC

Organoids creation

Intervention Type OTHER

Organoids are created from discarded tissue

Interventions

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Organoids creation

Organoids are created from discarded tissue

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infants, with a postconceptional age below 44 weeks of gestation, undergoing a clinically indicated intervention of partial intestinal resection while hospitalized at the NICU of the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico.