Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

March 15, 2024

Primary Completion Date

March 14, 2026

Study Completion Date

February 28, 2027

Conditions
Neonatal SepsisShock, Septic
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

Trial Locations (1)

160012

Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh

All Listed Sponsors
lead

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

NCT06306001 - Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock | Biotech Hunter | Biotech Hunter