Clinical trials: Necrotizing Enterocolitis of Newborn
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
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
Necrotizing Enterocolitis of Newborn, Sepsis Newborn
Single Vs Multi-strain Probiotics for Preterm Neonates
The goal of this randomized control clinical trial is to determine if probiotics can prevent mortality and morbidity in preterm neonates. It also evaluates effects of probiotics on feeding pattern and growth.
- Conditions
- Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Growth, Feeding Intolerance
- Trial name
- NCT07296718
- Testing
- Dextrose 10%, Lactobacillus Rhamnosus GG, Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4
- Where
- Pakistan
- Volunteers
- 249 people
- Sponsor
- Madiha, MPhil
Necrotizing Enterocolitis of Newborn
Role of Probiotic Use in Outcomes of Premature Birth
Project Summary: The prevalence of preterm birth ranges from 5% to 18% across 184 countries, and an estimated 15 million infants are born preterm globally.
- Trial name
- NCT05710575
- Testing
- probiotic
- Where
- Pakistan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Health Sciences Lahore
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
Neonatal Disease, Necrotizing Enterocolitis
A Genome-Wide Association Study for Neonatal Diseases
This is an observational study to identify genetic risks for neonatal diseases, necrotizing enterocolitis (NEC) using genome-wide association study (GWAS) and enterotype investigation.
- Trial name
- NCT04074824
- Where
- Hong Kong
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Chinese University of Hong Kong
Necrotizing Enterocolitis of Newborn, Bowel Ischemic
CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis
There is no bedside imaging technique that can quantify dynamic bowel perfusion with high soft tissue contrast and sensitivity in necrotizing enterocolitis (NEC).
- Trial name
- NCT03549507
- Testing
- Sulfur hexafluoride lipid-type A microspheres
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Children's Hospital of Philadelphia
Necrotizing Enterocolitis of Newborn
Necrotizing Enterocolities
Haematological disturbances in neonates with necrotizing enterocolities
- Trial name
- NCT06632041
- Testing
- Complete blood count
- Volunteers
- 70 people
- Sponsor
- Assiut University
Necrotizing Enterocolitis of Newborn, Feeding Intolerance
Impact of Enteral Feeding on Splanchnic Oxygenation During Packed Red Blood Cell Transfusion in Preterm Infants
This clinical trial aims to learn if enteral feeding influences cerebral and splanchnic oxygenation during red blood cell infusion in very low birth-weight preterm infants.
- Conditions
- Necrotizing Enterocolitis of Newborn, Feeding Intolerance, PreTerm Neonate, Transfusion Related Complications
- Trial name
- TANEC (NCT06632314)
- Testing
- Enteral feeding
- Where
- Turkey (Türkiye)
- Volunteers
- 45 people
- Sponsor
- Akdeniz University
Feeding; Difficult, Newborn, Growth Failure
Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections.
- Conditions
- Feeding; Difficult, Newborn, Growth Failure, Necrotizing Enterocolitis, Sepsis
- Trial name
- PROPEL (NCT01603368)
- Testing
- Lactobacillus reuteri
- Where
- 2 sites in Sweden
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Ostergotland County Council, Sweden
Infant, Newborn, Infant, Low Birth Weight
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEST (NCT01029353)
- Testing
- Laparotomy, Drainage
- Where
- 22 sites in United States
- Volunteers
- 529 people
- Sponsor
- NICHD Neonatal Research Network
Gastric Residuals Assessment, Prematurity
Does Routine Assessment of Gastric Residuals in Preterm Neonates Influence Time Taken to Reach Full Enteral Feeding?
The study aims to compare routine assessment of gastric residuals versus no assessment of residuals in preterm neonates with respect to time taken for achieving full enteral feeding and the incidence of possible complications…
- Conditions
- Gastric Residuals Assessment, Prematurity, Sepsis Newborn, Necrotizing Enterocolitis of Newborn
- Trial name
- GRASS (NCT03111329)
- Testing
- No aspiration of gastric residuals
- Where
- 2 sites in Czechia, Ireland
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Institute for the Care of Mother and Child, Prague, Czech Republic
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
Infant, Newborn, Asphyxia Neonatorum
Optimising Newborn Nutrition During Therapeutic Hypothermia.
The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia.
- Conditions
- Infant, Newborn, Asphyxia Neonatorum, Hypothermia, Induced, Parenteral Nutrition
- Trial name
- NCT03278847
- Testing
- Received enteral (milk) feeds during therapeutic hypothermia, Enteral (milk) feeds withheld during therapeutic hypothermia, Received parenteral nutrition during therapeutic hypothermia
- Where
- 2 sites in United Kingdom
- Volunteers
- 6,030 people
- Sponsor
- Imperial College London
Feeding; Difficult, Newborn, Necrotizing Enterocolitis
A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants
The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34 weeks corrected gestation age (CGA) ; 2)…
- Trial name
- NCT01337921
- Testing
- Multi-strain Probiotic
- Sponsor
- University of Nebraska
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 of Newborn
The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis
Study Description The goal of this observational study is to detect intestinal flora and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. The main questions it aims to answer are: 1.
- Trial name
- NCT05619055
- Testing
- Routine treatment
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zuohui Zhao
Total Parenteral Nutrition, Necrotizing Enterocolitis of Newborn
Probiotics/TPN in the NICU
The purpose of this study is to evaluate the effect of probiotic administration on TPN dependence in infants < 32 weeks GA and BW 1500 grams or less in the Banner - University Medical Center Phoenix and Banner Children's at…
- Trial name
- NCT04977817
- Testing
- Similac Probiotic Tri-Blend
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Pediatrix
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, Necrotizing Enterocolitis of Newborn
Infant Formula Feeding and Necrotizing Enterocolitis in Newborns
Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.
- Conditions
- Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Cows Milk Allergy
- Trial name
- NCT05121753
- Testing
- Survey investigating Infant formula feeding in newborns
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Neuroganics LLC