Clinical trials: Enterocolitis
Antibiotic Enterocolitis
Effect of Antibiotics on Enteric Neurons and Glia
The interactions between bacteria and their products with the intestinal tissue are important for maintaining a healthy and balanced system.
- Trial name
- NCT05834036
- Testing
- Amoxicillin Oral Capsule
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Rockefeller University
Necrotizing Enterocolitis
Analysis of Integrated Clinical, Laboratory and Prognostic Data of Neonates With Necrotizing Enterocolitis
This is a retrospective study led by The Sixth Affiliated Hospital, Sun Yat-sen University, focusing on newborns diagnosed with necrotizing enterocolitis (NEC)-a serious gastrointestinal disease that threatens newborns'…
- Trial name
- ACLPNEC (NCT07207915)
- Testing
- Observational retrospective cohort study
- Where
- China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Necrotizing Enterocolitis
Risk Factors for Poor Prognosis in Neonatal Necrotizing Enterocolitis
This is a retrospective study led by Guangzhou Women and Children's Medical Center, focusing on newborns diagnosed with necrotizing enterocolitis (NEC)-a serious gastrointestinal disease that threatens newborns' lives-between…
- Trial name
- RFPNEC (NCT07249697)
- Testing
- Observational retrospective cohort study
- Where
- China
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Guangzhou Women and Children's Medical Center
Intraventricular Hemorrhage, Pulmonary Hemorrhage
Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality
This study aims to understand the role of extracellular vesicles (EVs) in extremely premature infants, those born before 28 weeks of gestation.
- Conditions
- Intraventricular Hemorrhage, Pulmonary Hemorrhage, Death, ELGAN (22-28SA)
- Trial name
- VEEP (NCT07273643)
- Testing
- Venous Cord blood sample, Arterial cord blood sample
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Montpellier
Sepsis, Necrotising Enterocolitis Neonatal
Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis
Behind the scenes pilot trial in the computer lab involving chart review to use neonatal intensive care unit data to create computer models predicting sepsis and necrotizing enterocolitis in very small premature infants
- Trial name
- PREMO (K) (NCT07254559)
- Testing
- No Intervention: Observational Cohort
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- University of Virginia
Very Preterm Infants (<32 Weeks of Gestation)
Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing…
- Trial name
- AdVEMPrem (NCT07402083)
- Testing
- Donor human milk extracellular vesicles (DHM-EVs)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
Necrotizing Enterocolitis
RIC-NEC Randomized Controlled Trial
Necrotizing enterocolitis (NEC) is a serious intestinal disease of preterm and term neonates which remains a major cause of intestinal failure, and an unsolved clinical challenge in pediatrics.
- Trial name
- RIC-NEC (NCT05279664)
- Testing
- Remote ischemic conditioning (RIC) + Standard of Care for NEC, Standard of Care for NEC
- Where
- 4 sites in United States, Canada
- Volunteers
- 78 people
- Sponsor
- The Hospital for Sick Children
Necrotizing Enterocolitis of Newborn, Sepsis Newborn
Single Vs Multi-strain Probiotics for Preterm Neonates
The goal of this randomized control clinical trial is to determine if probiotics can prevent mortality and morbidity in preterm neonates. It also evaluates effects of probiotics on feeding pattern and growth.
- Conditions
- Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Growth, Feeding Intolerance
- Trial name
- NCT07296718
- Testing
- Dextrose 10%, Lactobacillus Rhamnosus GG, Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4
- Where
- Pakistan
- Volunteers
- 249 people
- Sponsor
- Madiha, MPhil
Necrotizing Enterocolitis (NEC)
NETs: Protection or Harm in Neonatal Inflammation or Infection
This is a prospective in vitro cell biology study of polymorphonuclear leukocyte (PMN) protein synthesis in response to PAF. PMNs from cord blood of premature human infants at risk for NEC (birth weight between 501 - 1500 grams)…
- Trial name
- NCT00747851
- Where
- United States
- Volunteers
- 388 people, healthy volunteers welcome
- Sponsor
- University of Utah
Shock, Preterm Birth Complication
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g.
- Conditions
- Shock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia Perinatal
- Trial name
- NCT07248761
- Testing
- Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Necrotizing Enterocolitis
Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis
The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.
- Trial name
- NCT05573113
- Testing
- Bowel Ultrasound, Abdominal radiograph
- Where
- 2 sites in United States
- Volunteers
- 169 people
- Sponsor
- Children's Mercy Hospital Kansas City
Necrotizing Enterocolitis, Intestinal Ischemia
Phase I Clinical Study of Chondroitin Sulfate for Treatment of NEC
The goal of this phase 1 double blind, randomized controlled trial is to determine the safety of chondroitin sulfate supplementation in the neonates with necrotizing enterocolitis.
- Trial name
- NCT06547424
- Testing
- Chondroitin sulfate
- Where
- United States
- Sponsor
- Indiana University
Necrotizing Enterocolitis of Newborn
Role of Probiotic Use in Outcomes of Premature Birth
Project Summary: The prevalence of preterm birth ranges from 5% to 18% across 184 countries, and an estimated 15 million infants are born preterm globally.
- Trial name
- NCT05710575
- Testing
- probiotic
- Where
- Pakistan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Health Sciences Lahore
Enteropathy, Necrotizing Enterocolitis
Use of Faecal Calprotectin to Predict Enteropathy of the Preterm Neonates
This study aims to evaluate a clinico-biological predictive score, associating the faecal calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates.
- Trial name
- CALPROPREMA (NCT02010268)
- Testing
- Collection of stool samples
- Where
- France
- Volunteers
- 122 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Necrotising Enterocolitis Neonatal
Effects of Implementation of a Care Bundle on Rates of NEC and Own Mother's Milk Feeding in the East Midlands
Necrotising enterocolitis (NEC) is a life-threatening gut disease in babies born early. Feeding preterm babies their own mother's milk prevents NEC.
- Trial name
- EMNODN-NEC (NCT05934123)
- Testing
- EMNODN NEC Care Bundle
- Where
- United Kingdom
- Volunteers
- 53,600 people
- Sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn
Amniotic Fluid & the Preterm Gut
Background: Necrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations.
- Conditions
- Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn, Necrotizing Enterocolitis of Newborn, Neonatal Sepsis, Early-Onset
- Trial name
- AMFIBIE (NCT07152106)
- Where
- 2 sites in Netherlands
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Maxima Medical Center
Congenital Heart Disease
Calprotectin and Gut Disease Study
Necrotising enterocolitis (NEC) is a serious gut disease that can develop in infants born with cardiac defects. It causes inflammation and injury to the gut mucosa and may be life-threatening.1 The aetiology of NEC in cardiac…
- Trial name
- SAFE NEC (NCT07112794)
- Volunteers
- 300 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Hirschsprung Disease, Enterocolitis
Probiotics and Post-Pullthrough Hirschsprung's Disease-Associated Enterocolitis
This was a prospective case-controlled study investigating the role of probiotics in the management of Hirschsprung-associated enterocolitis (HAEC).
- Conditions
- Hirschsprung Disease, Enterocolitis, Hirschsprung's Disease Associated Enterocolitis
- Trial name
- NCT07098494
- Testing
- Saccharomyces Boulardii Probiotic Supplement
- Where
- Egypt
- Volunteers
- 88 people
- Sponsor
- Aswan University Hospital
Late-Onset Neonatal Sepsis, Necrotising Enterocolitis
Markers of Platelet Activation foR Identification of Late Onset Sepsis in Preterm Infants
The PARENT study will examine platelet and endothelial associated proteins in preterm infants being investigated for late onset sepsis (LOS) to see if infants with fulminant sepsis can be prospectively identified using these…
- Conditions
- Late-Onset Neonatal Sepsis, Necrotising Enterocolitis, Culture Negative Neonatal Sepsis
- Trial name
- PARENT (NCT05530330)
- Testing
- Platelet/Endothelial proteomics
- Where
- 2 sites in Ireland
- Volunteers
- 268 people
- Sponsor
- University College Dublin
Neonatal Disease, Necrotizing Enterocolitis
A Genome-Wide Association Study for Neonatal Diseases
This is an observational study to identify genetic risks for neonatal diseases, necrotizing enterocolitis (NEC) using genome-wide association study (GWAS) and enterotype investigation.
- Trial name
- NCT04074824
- Where
- Hong Kong
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Chinese University of Hong Kong