Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock

What Was Tested

The trial (phase 2, phase 3) is built around Methylene blue (non-peptide stack partner).

The main questions that this study aims to answer is: 1.

It had two arms (groups): Methylene blue (experimental) and Placebo infusion (placebo comparator).

Subjects in the control arm will receive a placebo infusion (normal saline) at the same volumetric rate.

The registry classes the interventions as drug and other.

More on the Plan

Preterm infants with definite or probable sepsis and fluid-refractory, catecholamine-resistant septic shock will be eligible for enrolment if they have no contraindication to receive MB.

After obtaining parental consent, they will be stratified as per the first-line catecholamine used and randomly allocated to receive MB (bolus followed by infusion) or no MB for 24 hours.

They will be observed for all-cause mortality (primary outcome), cause-specific mortality, time to achieve hemodynamic stability and adverse effects (secondary outcomes) over a 7-day period, all-cause mortality and cause-specific mortality hospital stay and duration of hospital stay.

The main questions it aims to answer are 1.

Who Took Part

The registry lists 130 planned participants were the target.

It was open to people of any sex aged from 0 Days up to 28 Days.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Shock: adapted from the definition given by Davis et al 2017. Either SBP \< age and gestation appropriate cut-off OR.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: G6PD deficient or family history of G6PD deficiency; potentially lethal malformation; congenital heart disease.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

As a double-blind Methylene blue (non-peptide stack partner) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2024-03-15 with completion listed for 2026-03-14.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): All-cause mortality within 7 days after randomization (time frame: 7 days).

It also tracked 16 secondary outcomes, for example Time taken to achieve therapeutic end-points within 7 days after randomization, Time taken to stop all inotrope/vasopressor treatment within 7 days after randomisation, Echocardiographic fractional shortening at 24 hour after randomization, Left ventricular end-diastolic diameter (LVEDD) by echocardiography at 24 hour after randomization, Left ventricular end-systolic diameter (LVESD) by echocardiography at 24 hour after randomization and Aortic diameter by echocardiography at 24 hour after randomization.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Methylene blue (non-peptide stack partner) in 130 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.