Clinical trials: Enterocolitis, Necrotizing
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
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
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, Premature Birth
Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants
Compare the bacterial digestive microbiota during the stay in neonatal intensive care between a group of premature newborns developing a NEC (necrotizing enterocolitis) and a group of newborns free from NEC.
- Trial name
- CortECS (NCT04972734)
- Testing
- premature newborns developing a NEC, premature newborns without NEC
- Where
- France
- Volunteers
- 297 people
- Sponsor
- University Hospital, Clermont-Ferrand
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
NEC, NEC - Necrotizing Enterocolitis
Assessing the Efficacy of Probiotics in Prevention of NEC in Preterm Babies
The goal of the study is to check efficacy of probiotics in preventing necrotizing enterocolitis. The main questions would be if the preterm baby developed NEC or not.
- Trial name
- NCT07233382
- Testing
- Probiotic, 10% dextrose
- Where
- Pakistan
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Hayatabad Medical Complex
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
Premature Birth, Neonatal Hypoglycemia
Higher-Dose Dexamethasone Improves Breathing and Shortens NICU Stay in Preterm Babies
The goal of this observational study was to compare two doses of dexamethasone given to pregnant women at risk of preterm birth. Dexamethasone is a medicine used before birth to help a baby's lungs mature.
- Conditions
- Premature Birth, Neonatal Hypoglycemia, Maternal Infection During Pregnancy, Neurodevelopmental Disorder of Foetus
- Trial name
- NCT07765329
- Testing
- Dexamethasone 12 mg Every 12 Hours, Dexamethasone 6 mg Every 12 Hours
- Where
- Indonesia
- Volunteers
- 200 people
- Sponsor
- Stella Maris Women and Children Hospital
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.
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
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
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
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
Anemia, Necrotizing Enterocolitis
RBC Irradiation, Anemia and Gut Injury
The purpose of this trial is to study the effect that anemia and red blood cell (RBC) transfusions have on oxygen levels in the digestive tracts of extremely low birth weight (ELBW) infants and to look for possible markers in a…
- Trial name
- RBC-mNIRS (NCT02741648)
- Testing
- Near Infrared Spectroscopy, Non-invasive Image-based Anemia Assessment
- Where
- 3 sites in United States
- Volunteers
- 324 people
- Sponsor
- Emory University
Necrotizing Enterocolitis, Time to Full Enteral Nutrition
Intestinal Lavage to Promote Enteral Feeding and Prevent Necrotizing Enterocolitis in Extremely Preterm Infants
Optimizing enteral nutrition (EN) is challenging in extremely preterm infants due to feeding intolerance that relates to the functional gastrointestinal immaturity.
- Trial name
- NCT03631979
- Testing
- Intestinal lavage with normal saline
- Where
- Sweden
- Volunteers
- 200 people
- Sponsor
- Uppsala County Council, Sweden
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
Poor Growth in Extremely Preterm Infants, Necrotizing Enterocolitis
Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants
The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or equal to 27 weeks.
- Trial name
- NCT04284280
- Testing
- Routine vs Selective use of Human Milk Donor Fortifier
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Crouse Hospital
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
Microbial Colonization, Extreme Prematurity
NICU Antibiotics and Outcomes Trial
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life.
- Conditions
- Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis, Late-Onset Neonatal Sepsis
- Trial name
- NANO (NCT03997266)
- Testing
- Ampicillin, Gentamycin, Normal saline
- Where
- 14 sites in United States
- Volunteers
- 359 people
- Sponsor
- Michael Morowitz
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