Study of ST266 for Necrotizing Enterocolitis in Infants
This study is testing ST266, a biological treatment, in infants with Necrotizing Enterocolitis (NEC), a serious intestinal disease. Researchers want to see if ST266 is safe and tolerable, and if it shows early signs of helping infants with NEC. Infants between 2 and 8 weeks old, weighing between 500g and 3000g, and born between 22 and 40 weeks gestational age, may be eligible. Some infants will receive ST266 along with their usual care, while others will receive only usual care. The main goal is to track any side effects and changes in lab tests and vital signs for up to 24 months to understand the safety of ST266. The current recruitment status is unclear.
- Study design
- This is a randomized, controlled, open-label study, meaning participants are assigned by chance to receive either ST266 or standard care, and both you and the study team will know which treatment is given. The study plans to enroll 36 infants.
- What's involved
- Patients randomized to ST266 will receive the drug once daily via IV for 10 days. All participants will have follow-up visits and evaluations.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and tolerability for up to 24 months of age after randomization.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)
At a glance
Conditions
Where it's being run
8 sites across 6 statesWho to contact
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What this trial measures
- Safety and Tolerability endpoint: incidence of adverse eventsFrom date of randomization through 24 months of age
Patients will be assessed for safety and tolerability of ST266 treatment given IV (two dose options: 0.5mL/kg or 1.0mL/kg) via review of treatment emergent adverse events (TEAEs). AEs are defined as per the International Neonatal Consortium (INC) neonatal AE severity scale (NAESS): Mild, Moderate, Severe, Life Threatening, Death. Relatedness to study drug (ST266) will also be assessed.
- Safety and Tolerability endpoint: incidence of serious adverse eventsFrom date of randomization through 24 months of age
Patients will be assessed for safety and tolerability of ST266 treatment given IV (two dose options: 0.5mL/kg or 1.0mL/kg) via review of serious adverse events, defined as: any event that results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or may jeopardize patient so that requires intervention to prevent prior noted outcomes (includes study drug related dose-limiting toxicities and infusion reactions)
- Safety and Tolerability endpoint: Changes in labs and vitals relative to disease progressionFrom date of randomization through 24 months of age
Patients will be assessed for safety and tolerability of ST266 treatment given IV (two dose options: 0.5mL/kg or 1.0mL/kg) by evaluating clinically significant changes in labs and vitals as to relatedness to disease progression and study drug effects, including assessment of vital signs (temperature, systolic and Mean arterial blood pressure (mmHg), respiratory rate, heart rate, and percent oxygen saturation as measured by pulse oximetry as noted in The Harriet Lane Handbook, 21st ed., 2018), and hematology and chemistry lab tests, which will be measured against standard laboratory acceptable ranges for premature infants.