Clinical trials: Necrotizing Enterocolitis, open to volunteers
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
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, Intestinal Perforation
Necrotizing Enterocolitis and Bowel Perforation in Very Preterm Infants - Long-term Follow up
Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and/or small bowel and subsequent intramural gas-forming organisms into the intestinal wall.
- Conditions
- Necrotizing Enterocolitis, Intestinal Perforation, Premature Infant Disease
- Trial name
- NOR-NEC (NCT06757582)
- Where
- Norway
- Volunteers
- 150 people
- Sponsor
- University Hospital of North Norway
Duct Dependent Lesions, Necrotising Enterocolitis
Enteral Feeding in Infants With Duct Dependant Lesions.
This is a multicenter randomised controlled trial to assess whether standardised enteral feeding in newborns with duct dependenty congenital heart disease decreases the risk of necrotising enterocolitis (NEC).
- Conditions
- Duct Dependent Lesions, Necrotising Enterocolitis, Death, Growth
- Trial name
- CARDIOFEED (NCT05117164)
- Testing
- enteral feeding as per predefined protocol
- Where
- 2 sites in Poland
- Volunteers
- 384 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Necrotizing Enterocolitis
WithHolding Enteral Feeds Around Blood Transfusion (International)
The WHEAT International trial is a comparative effectiveness trial exploring whether withholding enteral feeds around the time of blood transfusion in very premature infants (<30 weeks) will reduce the occurrence of Necrotizing…
- Trial name
- WHEAT (NCT05213806)
- Testing
- Withholding feeds around transfusion, Continued feeds around transfusion
- Where
- 40 sites in Canada, United Kingdom
- Volunteers
- 4,333 people
- Sponsor
- IWK Health Centre
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
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
Mullerian Anomaly of Vagina, Mullerian Anomaly of Uterus, Nec
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies (MULAN)
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 Vagina, Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Cervix
- Trial name
- MULAN (NCT04732546)
- Where
- Belgium
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Ghent
NEC - Necrotizing Enterocolitis
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
Necrotizing enterocolitis (NEC) is one of the most severe gastrointestinal emergencies in preterm infants, characterized by insidious onset, rapid progression, and high mortality.
- Trial name
- NCT07545993
- Testing
- No Intervention: Observational Cohort
- Volunteers
- 1,050 people
- Sponsor
- Guangzhou Women and Children's Medical Center
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
Necrotising Enterocolitis Neonatal
Neonatal Laparotomy - A Trial Investigating the Impact of Location of Surgery
This is a pilot randomised trial allocating neonates requiring emergency laparotomy to surgery either on the neonatal unit or in the operating theatre.
- Trial name
- NeoLap (NCT07754435)
- Testing
- IN theatre, ON unit
- Volunteers
- 15 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
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
Short Bowel Syndrome
A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients With Short Bowel Syndrome
A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients with Short Bowel Syndrome
- Trial name
- NCT05535361
- Testing
- Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Eclipse Regenesis, Inc.
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
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
Necrotizing Enterocolitis, Premature
Fecal Calprotectin in Breastfed vs Formula-Fed Preterm Infants and NEC
This prospective observational study aims to evaluate fecal calprotectin levels as an early indicator of necrotizing enterocolitis in preterm infants and to compare levels between breastfed and formula-fed preterm infants at…
- Conditions
- Necrotizing Enterocolitis, Premature, Breast Feeding
- Trial name
- NCT07810543
- Volunteers
- 112 people
- Sponsor
- Assiut University
Premature, Gut Microbiota Diversity and Composition
Effect of Rectal Administration of Breast Milk on Gut Microbiota in Preterm Infants
This study aims to evaluate the effect of rectal administration of maternal breast milk on gut microbiota development in preterm infants.
- Conditions
- Premature, Gut Microbiota Diversity and Composition, NEC - Necrotizing Enterocolitis
- Trial name
- premic (NCT07558499)
- Testing
- Rectal irrigation with maternal breast milk, Rectal irrigation with salin
- Volunteers
- 60 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
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
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)
The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or…
- Trial name
- NEC (NCT06315738)
- Testing
- ST266
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Noveome Biotherapeutics, formerly Stemnion
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
The Correlation Between Red Cell Transfusion and Complications of Prematurity
The aim of this clinical trial is to learn if there is a correlation between the erythrocyte transfusion in the early neonatal period in premature infants and early and late complications of prematurity.
- Conditions
- Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD), Enterocolitis, Necrotizing, Intraventricular Hemorrhage Neonatal
- Trial name
- NCT07123948
- Testing
- Wechsler Intelligence Test, performed by educated psychologists
- Where
- Croatia
- Volunteers
- 128 people
- Sponsor
- Clinical Hospital Center Rijeka