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NOT YET RECRUITING
NCT06306001
PHASE2/PHASE3

Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock

Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

OTHER

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