Clinical trials: Necrotizing Enterocolitis, active
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 (NEC), Necrotizing Enterocolitis of Newborn
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
The aim of the study is to assess the safety of fecal microbiota transplantation (FMT) as a preventive method for the development of Necrotizing enterocolitis (NEC) in a group of premature infants.
- Trial name
- NCT06333405
- Testing
- Fecal Microbiota Transplantation
- Where
- Poland
- Volunteers
- 40 people
- Sponsor
- Medical University of Warsaw
Necrotizing Enterocolitis
Qualitative Study of Surgeons With Prospective Patient Follow-up
Necrotising enterocolitis (NEC) is a devastating disease which causes severe bowel inflammation resulting in babies becoming critically unwell.
- Trial name
- NECqual (NCT06032676)
- Where
- United Kingdom
- Volunteers
- 75 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Vagina
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies
The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian…
- Conditions
- Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Vagina, Mullerian Anomaly of Cervix
- Trial name
- MULAN (NCT04627818)
- Where
- Belgium
- Volunteers
- 1,500 people
- Sponsor
- University Hospital, Ghent
Necrotizing Enterocolitis
Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization
The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control…
- Trial name
- ECUN-2 (NCT04584320)
- Testing
- Stool sample
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Preterm Birth Complication, Neonatal Morbidity and Mortality
Delayed Versus Immediate Cord Clamping in Preterm Birth
The goal of this study is to evaluate whether delayed cord clamping improves early neonatal outcomes compared with immediate clamping in preterm birth.
- Conditions
- Preterm Birth Complication, Neonatal Morbidity and Mortality, Cord Clamping, Delayed Cord Clamping
- Trial name
- PREM-CORD (NCT07699666)
- Testing
- Delayed Umbilical Cord Clamping, Immediate Umbilical Cord Clamping
- Where
- Tunisia
- Volunteers
- 200 people
- Sponsor
- Faculty of Medicine of Tunis
NEC - Necrotizing Enterocolitis
Antibiotic Exposure on Gut Microbiota and Motility Establishment in Newborns
This prospective cohort study aims to investigate the impact of early antibiotic exposure on the establishment of gut microbiota and motility in newborns, particularly preterm infants.
- Trial name
- NCT06850896
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Hospital of Jilin University
Enterostomy
Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)
The primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of…
- Trial name
- MUC-FIRE (NCT03469609)
- Testing
- mucous fistula refeeding
- Where
- 17 sites in Austria, Germany and 1 more
- Volunteers
- 120 people
- Sponsor
- University of Leipzig
Necrotizing Enterocolitis, Intestinal Atresia
Pattern And Outcome Of Neonatal Gastrointestinal Emergencies In Assiut University Children Hospital
This prospective observational study aims to evaluate the pattern, clinical presentation, complications, and short-term outcomes of neonates admitted with gastrointestinal emergencies to the NICU at Assiut University Children…
- Conditions
- Necrotizing Enterocolitis, Intestinal Atresia, Malrotation, Hirschsprung Disease
- Trial name
- NCT07526636
- Volunteers
- 120 people
- Sponsor
- Assiut University
Necrotizing Enterocolitis, Microbial Substitution
PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants
PrePhage - Fecal bacteriophage transfer for enhanced gastrointestinal tract maturation in preterm infants This pilot triol has the primary goal of demonstrating the safety of transferring viruses and proteins from healthy term…
- Trial name
- NCT05272579
- Testing
- Fecal Filtrate Transfer
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
NEC - Necrotizing Enterocolitis, NEC
Mechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions
MAGPIE-2 is a prospective observational study designed to investigate the physiological mechanisms linking blood transfusion and enteral feeding practices to gut perfusion and oxygenation in very preterm infants.
- Conditions
- NEC - Necrotizing Enterocolitis, NEC, Preterm Babies, Preterm Infant Health
- Trial name
- MAGPIE-2 (NCT07191678)
- Where
- United Kingdom
- Volunteers
- 270 people
- Sponsor
- Imperial College Healthcare NHS Trust
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
Preterm Birth, Enterocolitis, Necrotizing
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Ulcerative-necrotizing enterocolitis (ECUN) is an infectious and inflammatory disease of the digestive tract, which can lead to intestinal necrosis or perforation.
- Trial name
- NECO2 (NCT05882448)
- Testing
- laparotomy, Laparoscopy
- Where
- 2 sites in France
- Volunteers
- 54 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Necrotizing Enterocolitis, Allergy
Investigation of Allergen Sensitization in Newborn Babies Diagnosed With Necrotizing Enterocolitis.
To evaluate the frequency of allergy between 12 and 24 months of age in infants who were treated in the neonatal clinic and had NEC.
- Conditions
- Necrotizing Enterocolitis, Allergy, Preterm
- Trial name
- AlisNEC (NCT07562009)
- Testing
- skin prick test
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Saglik Bilimleri Universitesi
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
Necrotising Enterocolitis Neonatal, Nutrition Disorder, Child
Long-term Nutritional Impact of Necrotizing Enterocolitis in Premature Newborns.
With premature newborn increase survival, the risk of serious neonatal morbidity, such as necrotizing enterocolitis (NEC), also increased.
- Conditions
- Necrotising Enterocolitis Neonatal, Nutrition Disorder, Child, Oral Disorders
- Trial name
- PremGrowth (NCT07490834)
- Testing
- Observation of related perinatal and postnatal factors
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Central Hospital, Nancy, France
Necrotizing Enterocolitis
Application of Transcriptome Sequencing Combined With Family-Based Whole Genome Sequencing in Improving Precise Diagnosis of Critically Ill Newborns in Northeast China
Background: Birth defects and genetic diseases are major threats to infant health. Many genetic diseases present atypically in newborns, who often have critical conditions, rapid progression, and high mortality.
- Trial name
- NCT06990334
- Testing
- Whole genome sequencing analysis
- Volunteers
- 1,000 people
- Sponsor
- The First Hospital of Jilin University
Necrotizing Enterocolitis, Death
Probiotic Supplementation in Extremely Preterm Infants in Scandinavia
The primary aim of this research is to determine whether supplementation with probiotics during the first weeks of life reduces the risk of necrotizing enterocolitis (NEC) and neonatal mortality and is safe to use among extremely…
- Conditions
- Necrotizing Enterocolitis, Death, Sepsis Newborn, Feeding Disorder Neonatal
- Trial name
- PEPS (NCT05604846)
- Testing
- ProPrems
- Where
- Sweden
- Volunteers
- 1,600 people
- Sponsor
- Region Stockholm
Necrotizing Enterocolitis (NEC), Healthy Control
Predictive Diagnosis of Ulcero-Necrotizing EnteroColitis in Premature Babies Using an Artificial Intelligence Approach Based on Early Analysis of the Fecal Microbiota
Prematurity affects around 7% of births in France. Necrotizing enterocolitis (NEC) is a dreaded digestive complication. It is responsible for a mortality rate ranging from 15 to 40%, a rate that has remained stable in recent…
- Trial name
- PECUNIA (NCT06727877)
- Testing
- Ability of early digestive microbiota analysis (using artificial intelligence) to predict the occurrence of NEC diagnosed according to the Bell classification.
- Where
- 5 sites in France
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University Hospital, Clermont-Ferrand