Phase I Clinical Study of Chondroitin Sulfate for Treatment of NEC (NCT06547424) | Clinical Trial Compass
WithdrawnPhase 1
Phase I Clinical Study of Chondroitin Sulfate for Treatment of NEC
Stopped: Project plan was abandoned.
United States0Started 2025-01
Plain-language summary
The goal of this phase 1 double blind, randomized controlled trial is to determine the safety of chondroitin sulfate supplementation in the neonates with necrotizing enterocolitis. The main questions the study aims to answer are:
Is chondroitin sulfate safe to administer in the neonatal NEC population, and will it have a beneficial profile in the short term intestinal and long term neurodevelopmental sequelae of NEC? Researchers will compare all cause mortality, progression to surgery, systemic inflammatory markers, and long term neurodevelopmental outcomes in those NEC patients who receive chondroitin sulfate compared to those who receive milk or formula placebo.
Who can participate
Age range1 Hour ā 6 Months
SexALL
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Inclusion criteria
ā. NICU patient at Riley Hospital for Children
ā. Weight of less than 2500g at time of NEC diagnosis
ā. Patient must have a diagnosis of Bell's Stage 2 necrotizing enterocolitis
Exclusion criteria
ā. Severe cardiac or neurological congenital anomalies
ā. Previous history of NEC
ā. History of abdominal surgery or other intestinal congenital anomalies
ā. Renal failure or renal impairment necessitating dialysis
ā. Any end-stage organ disease, infection, or condition, which in the opinion of the Investigator, makes the patient an unsuitable candidate for treatment
ā. Receipt of another investigational therapy
ā. Informed consent is unable to be obtained from parent or legally authorized representative