protocolSection identificationModule nctId: NCT06306001, orgStudyIdInfo id: IIRP-2023-1820/F1, briefTitle: Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-03-14, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Post Graduate Institute of Medical Education and Research, Chandigarh, class: OTHER, descriptionModule briefSummary: Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is:1. Whether MB treatment reduces death to any cause as compared to no MB treatment.2. Whether treatment with MB reduces the time to achieve normal blood pressure3. Whether treatment with MB reduces the time to stoppage of all blood pressure medications, steroids and normal saline.4. Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours., conditionsModule conditions: Neonatal Sepsis, conditions: Shock, Septic, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects will be randomly allocated to an intervention arm and a placebo arm. The 2 arms of the trial will run concurrently., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The random allocation will be concealed using serially numbered opaque sealed envelopes. After opening the envelope, a research nurse will administer a bolus of the study drug or placebo behind a screen, shielded from other staff. The infusion will be drawn up in an opaque syringe by the research nurse and infused through an intravenous tubing covered completely with aluminum foil. The research nurses will not be masked to the study drug. The parents of the subject, the regular staff nurses and doctors working in the unit and the project coordinator will be masked., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Methylene Blue, interventions name: Placebo, outcomesModule primaryOutcomes measure: All-cause mortality within 7 days after randomization, secondaryOutcomes measure: Time taken to achieve therapeutic end-points within 7 days after randomization, secondaryOutcomes measure: Time taken to stop all inotrope/vasopressor treatment within 7 days after randomisation, secondaryOutcomes measure: Echocardiographic fractional shortening at 24 hour after randomization, secondaryOutcomes measure: Left ventricular end-diastolic diameter (LVEDD) by echocardiography at 24 hour after randomization, secondaryOutcomes measure: Left ventricular end-systolic diameter (LVESD) by echocardiography at 24 hour after randomization, secondaryOutcomes measure: Aortic diameter by echocardiography at 24 hour after randomization, secondaryOutcomes measure: Velocity time integral (LVI) by echocardiography at 24 hours after randomization, secondaryOutcomes measure: Echocardiographic fractional shortening at 48 hour after randomization, secondaryOutcomes measure: Left ventricular end-diastolic diameter (LVEDD) on echocardiography at 48 hour after randomization, secondaryOutcomes measure: Left ventricular end-systolic diameter (LVESD) by echocardiography at 48 hour after randomization, secondaryOutcomes measure: Aortic diameter by echocardiography at 48 hour after randomization, secondaryOutcomes measure: Velocity time integral (LVI) by echocardiography at 48 hours after randomization, secondaryOutcomes measure: Time taken to stop vasopressor treatment, secondaryOutcomes measure: Mortality during hospital stay, secondaryOutcomes measure: Serious adverse effects, secondaryOutcomes measure: Septic shock-related mortality, eligibilityModule sex: ALL, minimumAge: 0 Days, maximumAge: 28 Days, stdAges: CHILD, contactsLocationsModule locations facility: Post Graduate Institute of Medical Education and Research (PGIMER), city: Chandigarh, zip: 160012, country: India, geoPoint lat: 30.73629, lon: 76.7884, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-01-22, uploadDate: 2024-03-01T05:10, filename: Prot_SAP_000.pdf, size: 210368, hasResults: False