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Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock

NCT06306001 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

  • Neonatal Sepsis
  • Shock, 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

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Sourabh Dutta, MD, PhD · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2026-03-14
Completion
2027-02-28

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06306001 on ClinicalTrials.gov