Clinical trials: Necrotising Enterocolitis Neonatal
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.
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
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
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
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
Hyaline Membrane Disease, Necrotizing Enterocolitis of Newborn
The Effect of β-Carotene, Vitamin D3 and Zinc on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates
Hyaline membrane disease, now commonly called respiratory distress syndrome (RDS), and feeding intolerance, which can lead to necrotizing enterocolitis (NEC), are two key morbidities found in premature neonates which resulted in…
- Trial name
- NCT03366584
- Testing
- Beta carotene, Vitamin D3, Zinc
- Where
- Indonesia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Late Onset Neonatal Sepsis, Necrotizing Enterocolitis
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates.
- Conditions
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis, Infant, Very Low Birth Weight
- Trial name
- NCT02073214
- Testing
- Probiotic
- Volunteers
- 182 people
- Sponsor
- IBSS Biomed S.A.
Late Onset Neonatal Sepsis, Necrotising Enterocolitis
Lactoferrin Prophylaxis in VLBW and Regulator T-cells
The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis and the effect of LF on regulatory T cells.
- Conditions
- Late Onset Neonatal Sepsis, Necrotising Enterocolitis, Very Low Birth Weight Infants
- Trial name
- NCT01287507
- Testing
- Lactoferrin (bovine origin)
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Ankara University
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
Necrotizing Enterocolitis
Early Predictors of Necrotizing Enterocolitis in Neonates
The goal of this project is to identify neonates who are predisposed to Necrotizing Enterocolitis (NEC). the investigators will determine the effectiveness of non-invasive measures as well as biochemical markers to identify…
- Trial name
- NCT03210831
- Where
- United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Nationwide Children's Hospital
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
Human Milk Fortification, Very Low Birth Weight Baby
Enrichment of Human Milk With Human and Bovine Milk-based Fortifiers for Very Preterm Infants: a Meta-analysis
Research has shown that provision of mother's milk is the optimal way to feed very low birthweight (VLBW) infants. Many infants will require a supplement to mother's milk, pasteurized donor human milk (PDHM) compared to preterm…
- Conditions
- Human Milk Fortification, Very Low Birth Weight Baby, Human Milk Nutrition, Human Milk Feeding
- Trial name
- NCT06870318
- Testing
- No intervention; Observational study
- Where
- 2 sites in Canada, Sweden
- Volunteers
- 355 people
- Sponsor
- The Hospital for Sick Children
Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal
Zinc Supplementation on Very Low Birth Weight Infant
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the…
- Conditions
- Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia, Retinopathy of Prematurity
- Trial name
- NCT04050488
- Testing
- Zinc Sulfate
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Necrotizing Enterocolitis of Newborn, Risk Factors
Risk Factors of Necrotizing Enterocolitis in Premature Newborns
With premature newborn increase survival, the risk of serious neonatal morbidity, such as necrotizing enterocolitis (NEC), also increased.
- Trial name
- ECUNancyLyon (NCT04719546)
- Testing
- Observation of related perinatal factors
- Where
- 2 sites in France
- Volunteers
- 459 people
- Sponsor
- Central Hospital, Nancy, France
Necrotizing Enterocolitis of Newborn
The Relationship Between Erythrocyte Transfusion and Nutrition and Necrotizing Enterocolitis in Preterm Infants
In this study; The aim of this study was to investigate the changes in fasting and dietary and mesenteric blood flow in the acute period during and after transfusion and to evaluate the necrotizing enterocolitis.
- Trial name
- NCT04083638
- Testing
- IFAB
- Where
- Turkey (Türkiye)
- Volunteers
- 81 people
- Sponsor
- Dr. Behcet Uz Children's Hospital