Clinical trials: NEC - Necrotizing Enterocolitis
Enterocolitis, Necrotizing, Bacteremia
Antibiotic "Dysbiosis" in Preterm Infants
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing…
- Conditions
- Enterocolitis, Necrotizing, Bacteremia, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
- Trial name
- NCT02784821
- Testing
- Antibiotic, Gastric fluid, Breast milk
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Florida
Necrotizing Enterocolitis
STP206 for the Prevention of Necrotizing Enterocolitis (NEC)
This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates.
- Trial name
- NCT01954017
- Testing
- STP206, Control
- Where
- 13 sites in United States
- Volunteers
- 103 people
- Sponsor
- Leadiant Biosciences, Inc.
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
Postnatal Growth Restriction, Necrotizing Enterocolitis
Human Milk-derived Fortification in Preterm Infants
Human Milk alone is unable to meet the high nutritional requirements of preterm infants. The American Academy of Pediatrics recommends fortification of human milk as a standard practice in all very low birth weight (VLBW)…
- Trial name
- NCT05228847
- Testing
- Human milk-derived HMF, bovine milk-derived HMF
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- University of Calgary
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
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
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
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
Pilot Study of the Feasibility of Feeding Preterm Infants With Fresh Versus Frozen Mother's Own Breast Milk in the NICU
Necrotizing enterocolitis (NEC) is a severe inflammatory disorder of the intestine that primarily affects very low birth weight (<1,500 g)/very preterm infants (≤32 weeks' gestation); it is also the leading cause of death in the…
- Trial name
- NCT03258957
- Testing
- Fresh Milk
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Huiqing Sun
Necrotizing Enterocolitis
Ultrasound, Doppler ,and Calprotectin in Necrotizing Enterocolitis Diagnosis
Necrotizing enterocolitis continues to be a disease that is associated with significant morbidity and mortality in premature infants due to advances in neonatal intensive care that increase the survival rate of extremely low…
- Trial name
- NCT03257553
- Testing
- fecal calprotectin , doppler and ultrasound
- Volunteers
- 50 people
- Sponsor
- Assiut University
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, Sepsis
The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants
Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants…
- Trial name
- NCT01807858
- Testing
- Bifidobacterium lactis, Bifidobacterium lactis plus İnülin, Maltodextrin
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Dr. Sami Ulus Children's Hospital
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
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
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
Necrotizing Enterocolitis, Enterocolitis, Necrotizing
Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis
Prophylactic probiotics have been shown to decrease the incidence of Necrotizing Enterocolitis (NEC) in premature neonates. However, there is some resistance to giving live bacteria to small babies.
- Trial name
- NCT02796703
- Testing
- Heat Inactivated probiotics
- Where
- Israel
- Volunteers
- 450 people
- Sponsor
- Shaare Zedek Medical Center
Necrotizing Enterocolitis, Very Low Birth Weight Infants
Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 gr.
- Trial name
- NCT01315821
- Testing
- Saccharomyces boulardii
- Where
- Turkey (Türkiye)
- Volunteers
- 220 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Premature, Necrotizing Enterocolitis
Intestinal Perfusion After Feeding in Preterm and Term Infants
This is a pilot exploratory observational prospective cohort phase I study. In this study, we will gather preliminary data to evaluate (i) the magnitude of changes in blood flow in the bowel before and after feeding and (ii) the…
- Trial name
- NCT06319326
- Testing
- Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding.
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Parenteral Nutrition, Necrotizing Enterocolitis
Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children
Manganese (Mn) is an essential metal required for normal growth and development. However, exposure to high Mn levels can be toxic to the brain.
- Conditions
- Parenteral Nutrition, Necrotizing Enterocolitis, Digestive System Abnormalities, Cholestasis
- Trial name
- NCT00392730
- Testing
- Remove Mn from PN if evidence of increased brain Mn on MRI
- Where
- United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born…
- Trial name
- NCT07045844
- Testing
- Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm Formula for Insufficient Breastfeeding, Routine fortification
- Where
- 24 sites in China
- Volunteers
- 2,324 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine