Clinical Trials Logo

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

n/a


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
Email paola.roggero@unimi.it
Status Not yet recruiting
Phase
Start date November 1, 2020
Completion date February 17, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT03670732 - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure N/A
Completed NCT05322161 - Yoga in the NICU for Parents Study N/A
Recruiting NCT04542096 - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting NCT04911452 - Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants N/A
Recruiting NCT02901652 - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome N/A
Completed NCT02148965 - Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial N/A
Completed NCT02273843 - A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis Phase 1
Terminated NCT02032511 - Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP) N/A
Completed NCT01721629 - Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants N/A
Terminated NCT01819532 - Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks N/A
Completed NCT01478711 - Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants N/A
Completed NCT00951860 - Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort N/A
Completed NCT01523769 - Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants N/A
Completed NCT00787124 - Transfusions and Nitric Oxide Level in Preterm Infants
Completed NCT00749008 - Study of Generalized Movements for Early Prediction of Cerebral Palsy N/A
Terminated NCT00486395 - Will CPAP Reduce Length Of Respiratory Support In Premature Infants? Phase 3
Terminated NCT01208493 - Dietary Protein in the Very-low-birth-weight Infant N/A
Completed NCT00527956 - Facilitation and Barriers to Breastfeeding in the NICU N/A
Completed NCT03372590 - NEO Rehab for Infants at Risk of Cerebral Palsy N/A
Completed NCT00033917 - Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial Phase 3