Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock

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 pressure 3. 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.

NCT Number	NCT06306001
Lead Sponsor	Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions	Neonatal Sepsis, Shock, Septic
Enrollment	130 participants
Start Date	2024-03-15
Primary Completion	2026-03-14 (estimated)
Study Completion	2027-02 (estimated)
Updated on ClinicalTrials.gov	2024-03-12