NCT06547424

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 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
35mo left

Started Jan 2025

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Jan 2025Mar 2029

First Submitted

Initial submission to the registry

August 7, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

October 10, 2025

Status Verified

October 1, 2025

Enrollment Period

3.9 years

First QC Date

August 7, 2024

Last Update Submit

October 8, 2025

Conditions

Necrotizing EnterocolitisIntestinal Ischemia

Keywords

chondroitin sulfate

Outcome Measures

Primary Outcomes (2)

  • Mortality

    14 and 28 days post intervention

  • Progression to need for surgery

    Infants with Stage 2 NEC can progress to stage 3 NEC and require surgery to remove intestinal tissue. This rate will be compared in the intervention and placebo arms

    14 and 28 days post intervention

Secondary Outcomes (2)

  • Systemic inflammatory markers

    14 and 28 days post intervention

  • Neurodevelopmental impairment (NDI)

    1 and 2 years post intervention

Study Arms (2)

Chondroitin sulfate

EXPERIMENTAL

Neonates with Bell's Stage 2 NEC will receive chondroitin sulfate (20mg/kg/day) dissolved in 1-2 mil of milk or formula for 2 days

Drug: Chondroitin sulfate

Placebo

PLACEBO COMPARATOR

Neonates with Bell's Stage 2 NEC will receive 1-2 ml of milk or formula placebo for 2 days

Drug: Chondroitin sulfate

Interventions

Chondroitin sulfateDRUG

Neonates with Bell's Stage 2 NEC will be given chondroitin sulfate (20mg/kg/day) mixed with 1-2 ml of milk or formula for 2 days

Chondroitin sulfatePlacebo

Eligibility Criteria

Age1 Hour - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Chondroitin Sulfates

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ChondroitinGlycosaminoglycansPolysaccharidesCarbohydrates
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 9, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

October 10, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Results of the study will be published at completion

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
within 6 months of study completion

Locations

US(1)