Clinical trials: Necrotizing Enterocolitis (NEC)
Prematurity
Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis in Preterrms
Mother's milk samples will be collected during the routine expression of milk, using a hospital-grade electric breast pump, and will be stored in the NICU breastmilk refrigerator.
- Trial name
- NCT06459414
- Testing
- : Oropharyngeal Administration Of Colostrum
- Where
- Egypt
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Cairo University
Necrotizing Enterolitis
NIRS and Doppler to Predict NEC in Risk Neonates
The main objective is to evaluate the interest of cerebro-splanchnic oxygenation ratio (CSOR) for early diagnosis of necrotizing enterocolitis (NEC) in neonates with rectal bleeding and/or abdominal distension.
- Trial name
- NeoNIRS (NCT01833000)
- Testing
- Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler
- Where
- France
- Volunteers
- 45 people
- Sponsor
- University Hospital, Montpellier
Enterocolitis, Necrotizing, Atresia; Bowel
Timing of Stoma Closure in Neonates
Some babies require emergency surgery on their tummy in the first few months of life. This is most commonly because they were born prematurely and developed a bowel problem (called NEC) or a blockage of the bowel.
- Conditions
- Enterocolitis, Necrotizing, Atresia; Bowel, Gastroschisis, Meconium Ileus
- Trial name
- ToSCiN (NCT04713579)
- Testing
- No intervention - observational study
- Where
- United Kingdom
- Volunteers
- 56 people
- Sponsor
- Manchester University NHS Foundation Trust
Lung Disease, Brain Injury
Genomics, Single Nucleotide Polymorphisms (SNPs), and Clinical Neonatology
This research seeks to establish a neonatal DNA Tissue Bank to find out if differences in small segments of DNA predispose babies to Chronic Lung Disease (CLD), Periventricular Brain Injury (PVI), Necrotizing Enterocolitis (NEC)…
- Conditions
- Lung Disease, Brain Injury, Necrotizing Enterocolitis, Respiratory Failure
- Trial name
- NCT00315263
- Where
- 2 sites in United States
- Volunteers
- 63 people
- Sponsor
- Children's Mercy Hospital Kansas City
Necrotizing Enterocolitis, Death
The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis
The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight infants.
- Trial name
- NCT02552706
- Testing
- probiotics, glucose solution
- Where
- 4 sites in China
- Volunteers
- 270 people
- Sponsor
- Shenzhen Bao'an Maternal and Child Health Hospital
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
Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis
The aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis.
- Trial name
- NCT06422000
- Testing
- Pentoxifylline, Probiotic Formula
- Where
- Egypt
- Volunteers
- 75 people
- Sponsor
- Tanta University
Enterocolitis, Necrotizing, Premature Infant
NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies
The overall primary objective is to establish the feasibility and pilot the design and delivery of a diagnostic randomized controlled trial (RCT) of BUS (bowel ultrasound) for NEC evaluation which will lead to a successful…
- Trial name
- NCT03963011
- Testing
- Bowel Ultrasound
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Children's Mercy Hospital Kansas City
Enteral Feeding Intolerance, Necrotizing Enterocolitis
Bovine Colostrum for Preterm Newborns
Feeding intolerance is a common problem in very preterm infants due to their immature digestive system. This intolerance extends the time to full enteral feeding and thereby also prolongs the time on parenteral nutrition (PN).
- Conditions
- Enteral Feeding Intolerance, Necrotizing Enterocolitis, Late-Onset Neonatal Sepsis
- Trial name
- PreColos-RCT (NCT03085277)
- Testing
- Bovine Colostrum, Preterm Formula
- Where
- 8 sites in China
- Volunteers
- 350 people
- Sponsor
- Per Torp Sangild
Bowel Sounds, Spectral Analysis
Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis
The recording or bowels is easy and cheap. The investigators wonder if these sounds are modified in babies with high risk of necrotizing enterocolitis.
- Conditions
- Bowel Sounds, Spectral Analysis, Necrotizing Enterocolitis, Preterm Babies
- Trial name
- BHAPE (NCT05544097)
- Testing
- Recording of the bowel sounds
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Necrotising Enterocolitis
The Efficacy of Symbiotic on Cytokines
The aim of this prospective double blinded randomised study is to investigate the efficacy of symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L.
- Trial name
- NCT01899677
- Testing
- distilled water, symbiotic
- Where
- Turkey (Türkiye)
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sepsis, Necrotising Enterocolitis Neonatal
Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis
Behind the scenes pilot trial in the computer lab involving chart review to use neonatal intensive care unit data to create computer models predicting sepsis and necrotizing enterocolitis in very small premature infants
- Trial name
- PREMO (K) (NCT07254559)
- Testing
- No Intervention: Observational Cohort
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- University of Virginia
Necrotizing Enterocolitis
NEC Thermography Infrared Imaging Study
Necrotizing enterocolitis (NEC) is a devastating disease affecting the intestines of premature infants. It involves intestine swelling, tissue destruction, infection, and even death.
- Trial name
- NCT03994341
- Testing
- A FLIR Thermovision a320M thermal IR camera
- Where
- 2 sites in Canada
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Ottawa Hospital Research Institute
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
Necrotizing Enterocolitis
The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation
This study aims to compare the differences between three different feeding regimens on intestinal oxygenation during packed red blood cell (PRBC) transfusion in premature babies.
- Trial name
- NCT02733718
- Testing
- NIRS (near-infrared spectroscopy)
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people
- Sponsor
- Marmara University
Necrotizing Enterocolitis
A Biologic Validation of Biomarkers of Progressive NEC & Sepsis
Necrotizing enterocolitis (NEC) is a severe, sometimes life-threatening inflammation of the intestine that occurs most often in premature babies.
- Trial name
- NEC (NCT00588718)
- Where
- United States
- Volunteers
- 740 people
- Sponsor
- R. Lawrence Moss
Instrumental Delivery, NEC, Affecting Fetus or Newborn
PROPENSITY-ID: Sonographic and Clinical Assessment of Head Position Prior to Instrumental Delivery and Labour Outcomes
Instrumental delivery is performed in 3-15% of all births (1). Successful instrumental delivery avoids need for cesarean section with associated maternal surgical morbidity, risk from neonatal disimpaction and future pregnancy…
- Conditions
- Instrumental Delivery, NEC, Affecting Fetus or Newborn, Second Stage Cesarean Delivery, Occiput Position
- Trial name
- PROPENSITYID (NCT05557097)
- Testing
- Intrapartum sonography
- Where
- Italy
- Volunteers
- 2,282 people, healthy volunteers welcome
- Sponsor
- University of Parma
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
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
Blood Transfusion Complication, Necrotizing Enterocolitis
Splanchnic Oxygenation Response to Feeds in Preterm Neonates: Effect of Red Blood Cell Transfusion
Since 1987, red blood cell (RBC) transfusions have been proposed as a potential risk factor for necrotizing enterocolitis (NEC), which is one of the most severe gastrointestinal complications of prematurity.
- Conditions
- Blood Transfusion Complication, Necrotizing Enterocolitis, Enteral Feeding Intolerance, Preterm Infant
- Trial name
- NIRS_RBC (NCT03643458)
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna