Clinical trials: Necrotising Enterocolitis Neonatal, open to volunteers
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
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, 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
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
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
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
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
- Where
- 2 sites in China
- Volunteers
- 1,050 people
- Sponsor
- Guangzhou Women and Children's Medical Center
Premature, Skin to Skin Contact
Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study
This study is a multi-center, prospective pre-post clinical study conducted under the leadership of the Turkish Neonatal Society.
- Conditions
- Premature, Skin to Skin Contact, Breast Feeding, Necrotizing Enterocolitis
- Trial name
- TR-SSCinNICU (NCT06672913)
- Testing
- skin to skin contact care
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- Baskent University Ankara Hospital
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
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
Feeding Intolerance in Preterm, NEC
Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance Using Fecal Lipocalin-2 and Electrical Cardiometry
Prospective observational study to evaluate the efficiency of using electrical cardiometry in combination with fecal lipocalin-2 for prediction of NEC in preterm neonates with feeding intolerance
- Conditions
- Feeding Intolerance in Preterm, NEC, Electrical Cardiometry, PreTerm Neonate
- Trial name
- NCT06874153
- Where
- Egypt
- Volunteers
- 42 people
- Sponsor
- Ain Shams University
Preterm Infants, Term Infants
The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease
The goal of this observational study is to determine the normal development of the human intestinal immune system in premature and mature neonatal life and to determine the pathophysiology behind life-threatening gastrointestinal…
- Conditions
- Preterm Infants, Term Infants, Necrotising Enterocolitis, Atresia; Bowel
- Trial name
- INTINE (NCT06092463)
- Where
- 2 sites in Denmark
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
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
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
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.
Prematurity Complications
Gut Permeability and Microbiome in Preterm Infants
NEC, a life-threatening, GI emergency characterized by increased IP, affects approximately 7 to 10% of preterm neonates, and typically occurs within 7 to 14 days of birth with mortality as high as 30-50%.
- Trial name
- NCT07667049
- Testing
- measurement of intestinal permeability
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Maryland, Baltimore