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Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
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.
Official title: Intravenous Methylene Blue for Treating Fluid-refractory, Catecholamine-resistant, Neonatal Septic Shock: a Randomized, Placebo-controlled, Superiority Trial
Key Details
Gender
All
Age Range
0 Days - 28 Days
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2024-03-15
Completion Date
2027-02
Last Updated
2024-03-12
Healthy Volunteers
No
Conditions
Interventions
Methylene Blue
Subjects in the intervention arm will receive a 1 mg/kg bolus of methylene blue over 30 minutes, followed by an infusion of 0.15 mg/kg/h. The infusion rate may be increased in steps of 0.15 mg/kg/h every 30 minutes until a maximum of 0.5 mg/kg/h.
Placebo
Subjects in the placebo arm will receive normal saline in the same volumetric dose as methylene blue in the intervention arm
Locations (1)
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, India