Phase I Clinical Study of Chondroitin Sulfate for Treatment of NEC

Launched by INDIANA UNIVERSITY · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether chondroitin sulfate, a dietary supplement, is safe for newborns with a condition called necrotizing enterocolitis (NEC). NEC is a serious illness that affects the intestines of premature babies. The researchers want to find out if giving chondroitin sulfate can help these infants in the short term and support their brain development in the long term. They will compare outcomes, such as whether the babies need surgery or face other health issues, between those who receive chondroitin sulfate and those who receive a placebo (a harmless substitute like milk or formula).

To be eligible for this study, babies must be receiving care in the neonatal intensive care unit (NICU) at Riley Hospital for Children, weigh less than 2500 grams when diagnosed with NEC, and have a specific type of NEC known as Bell's Stage 2. However, babies with severe heart or brain problems, previous NEC, certain surgical histories, or other serious health issues won't be included. If a baby is chosen to participate, their health will be monitored closely throughout the study to ensure safety and to gather important information about the potential benefits of chondroitin sulfate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. NICU patient at Riley Hospital for Children
• • 2. Weight of less than 2500g at time of NEC diagnosis
• • 3. Patient must have a diagnosis of Bell's Stage 2 necrotizing enterocolitis
• Exclusion Criteria:
• • 1. Severe cardiac or neurological congenital anomalies
• • 2. Previous history of NEC
• • 3. History of abdominal surgery or other intestinal congenital anomalies
• • 4. Renal failure or renal impairment necessitating dialysis
• • 5. Any end-stage organ disease, infection, or condition, which in the opinion of the Investigator, makes the patient an unsuitable candidate for treatment
• • 6. Receipt of another investigational therapy
• • 7. Informed consent is unable to be obtained from parent or legally authorized representative
• • 8. Patient is a ward of the court system