Status:
WITHDRAWN
Phase I Clinical Study of Chondroitin Sulfate for Treatment of NEC
Lead Sponsor:
Indiana University
Conditions:
Necrotizing Enterocolitis
Intestinal Ischemia
Eligibility:
All Genders
1-6 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Necrotizing Enterocolitis (NEC) is a devastating intra-abdominal emergency that primarily affects premature infants and is characterized by abdominal distention, extreme illness, and intestinal necros...
Eligibility Criteria
Inclusion
- NICU patient at Riley Hospital for Children
- Weight of less than 2500g at time of NEC diagnosis
- Patient must have a diagnosis of Bell's Stage 2 necrotizing enterocolitis
Exclusion
- Severe cardiac or neurological congenital anomalies
- Previous history of NEC
- History of abdominal surgery or other intestinal congenital anomalies
- Renal failure or renal impairment necessitating dialysis
- Any end-stage organ disease, infection, or condition, which in the opinion of the Investigator, makes the patient an unsuitable candidate for treatment
- Receipt of another investigational therapy
- Informed consent is unable to be obtained from parent or legally authorized representative
- Patient is a ward of the court system
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2029
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06547424
Start Date
January 1 2025
End Date
March 1 2029
Last Update
October 10 2025
Active Locations (1)
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1
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202