protocolSection identificationModule nctId: NCT06315738, orgStudyIdInfo id: ST266-NEC-201, briefTitle: Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Noveome Biotherapeutics, formerly Stemnion, class: INDUSTRY, collaborators name: Parexel, descriptionModule briefSummary: The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL/kg and 1.0 mL/kg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC., conditionsModule conditions: Necrotizing Enterocolitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: ST266, outcomesModule primaryOutcomes measure: Safety and Tolerability endpoint: incidence of adverse events, primaryOutcomes measure: Safety and Tolerability endpoint: incidence of serious adverse events, primaryOutcomes measure: Safety and Tolerability endpoint: Changes in labs and vitals relative to disease progression, secondaryOutcomes measure: Efficacy endpoint: Time to pneumatosis resolution, secondaryOutcomes measure: Efficacy endpoint: Time to full enteral nutrition assessment, secondaryOutcomes measure: Efficacy endpoint: Incidence of abdominal surgical intervention, secondaryOutcomes measure: Efficacy endpoint: Change in Neonatal Sequential Organ Failure Assessment (nSOFA) score, otherOutcomes measure: Exploratory endpoint: All cause mortality, otherOutcomes measure: Exploratory endpoint: Length of stay in the NICU, otherOutcomes measure: Exploratory endpoint: Change in weight over time, otherOutcomes measure: Exploratory endpoint: Change in length over time, otherOutcomes measure: Exploratory endpoint: Change in head circumference over time, otherOutcomes measure: Exploratory endpoint: Number of significant apnea events/day over time, otherOutcomes measure: Exploratory endpoint: Number of significant bradycardia events/day over time, otherOutcomes measure: Exploratory endpoint: Number of significant temperature instability events/day over time, otherOutcomes measure: Exploratory endpoint: Time to return to normal bowel sounds, otherOutcomes measure: Exploratory endpoint: Change in serum C-reactive protein (CRP), otherOutcomes measure: Exploratory endpoint: Time to return to normal serum platelet count levels, otherOutcomes measure: Exploratory endpoint: Incidence of intestinal or colonic strictures, otherOutcomes measure: Exploratory endpoint: Incidence of sepsis, otherOutcomes measure: Exploratory endpoint: Incidence of retinopathy, otherOutcomes measure: Exploratory endpoint: Incidence of bronchopulmonary dysplasia (BPD), otherOutcomes measure: Exploratory endpoint: Incidence of pulmonary hypertension (PH), otherOutcomes measure: Exploratory endpoint: Incidence of periventricular leukomalacia, eligibilityModule sex: ALL, minimumAge: 2 Weeks, maximumAge: 8 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: BayCare Health System-St. Joseph's Women's Hospital, status: RECRUITING, city: Tampa, state: Florida, zip: 33607, country: United States, contacts name: Jenelle Ferry, MD, role: CONTACT, phone: 813-872-2924, email: jenelle.ferry@baycare.org, contacts name: Jenelle Ferry, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False