Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock
Status:
NOT_YET_RECRUITING
Trial end date:
2027-02-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
PHASE2
Details
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh