Clinical trials: Necrotizing Enterocolitis, open to volunteers
Premature, Skin to Skin Contact
Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study
This study is a multi-center, prospective pre-post clinical study conducted under the leadership of the Turkish Neonatal Society.
- Conditions
- Premature, Skin to Skin Contact, Breast Feeding, Necrotizing Enterocolitis
- Trial name
- TR-SSCinNICU (NCT06672913)
- Testing
- skin to skin contact care
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- Baskent University Ankara Hospital
Mullerian Anomaly of Vagina, Mullerian Anomaly of Uterus, Nec
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies (MULAN)
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 Vagina, Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Cervix
- Trial name
- MULAN (NCT04732546)
- Where
- Belgium
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Ghent
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
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
Feeding Intolerance in Preterm, NEC
Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance Using Fecal Lipocalin-2 and Electrical Cardiometry
Prospective observational study to evaluate the efficiency of using electrical cardiometry in combination with fecal lipocalin-2 for prediction of NEC in preterm neonates with feeding intolerance
- Conditions
- Feeding Intolerance in Preterm, NEC, Electrical Cardiometry, PreTerm Neonate
- Trial name
- NCT06874153
- Where
- Egypt
- Volunteers
- 42 people
- Sponsor
- Ain Shams University
Preterm Infants, Term Infants
The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease
The goal of this observational study is to determine the normal development of the human intestinal immune system in premature and mature neonatal life and to determine the pathophysiology behind life-threatening gastrointestinal…
- Conditions
- Preterm Infants, Term Infants, Necrotising Enterocolitis, Atresia; Bowel
- Trial name
- INTINE (NCT06092463)
- Where
- 2 sites in Denmark
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
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
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 (NEC)
Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants
The goal of this clinical trial is to evaluate whether multi-strain probiotics of lactobacillus and bifidobacterium can prevent necrotizing enterocolitis (NEC) in preterm infants born at less than 32 weeks of gestation.
- Trial name
- NCT06810154
- Testing
- Multi-strain probiotics
- Where
- 4 sites in Canada
- Volunteers
- 2,170 people
- Sponsor
- University of Calgary
Necrotizing Enterocolitis, Intestinal Perforation
Necrotizing Enterocolitis and Bowel Perforation in Very Preterm Infants - Long-term Follow up
Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and/or small bowel and subsequent intramural gas-forming organisms into the intestinal wall.
- Conditions
- Necrotizing Enterocolitis, Intestinal Perforation, Premature Infant Disease
- Trial name
- NOR-NEC (NCT06757582)
- Where
- Norway
- Volunteers
- 150 people
- Sponsor
- University Hospital of North Norway
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
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
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
Prematurity; Extreme, Prematurity; Decision Support
Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).
PREM-IMPACT is a UK-based observational study exploring how caring for a very premature baby-particularly one affected by necrotising enterocolitis (NEC)-impacts families over the first year after hospital discharge.
- Conditions
- Prematurity; Extreme, Prematurity; Decision Support, Necrotising Enterocolitis, Preterm
- Trial name
- PREM-IMPACT (NCT07192393)
- Where
- 7 sites in United Kingdom
- Volunteers
- 90 people
- Sponsor
- Imperial College London
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.
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
NEC, Necrotizing Enterocolitis
Study of Normal Intestinal Development and Disease in Premature and Term Neonates
Current research on early intestinal development is primarily performed in mouse models. While useful in many other ways, mouse models are not ideal for studying human intestine development as the timing of this process differs…
- Conditions
- NEC, Necrotizing Enterocolitis, Intestinal Disease, Human Development
- Trial name
- NiiCE (NCT06681129)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Children's Hospital
Necrotizing Enterocolitis (NEC)
NETs: Protection or Harm in Neonatal Inflammation or Infection
This is a prospective in vitro cell biology study of polymorphonuclear leukocyte (PMN) protein synthesis in response to PAF. PMNs from cord blood of premature human infants at risk for NEC (birth weight between 501 - 1500 grams)…
- Trial name
- NCT00747851
- Where
- United States
- Volunteers
- 388 people, healthy volunteers welcome
- Sponsor
- University of Utah