A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate
The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing methylene blue versus terlipressin in treatment of preterm neonate with catecholamines resistant septic shock the outcome as regard elevation of mean arterial blood pressure will be measured within 72 hours
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Methylene Blue group (Group MB):will receive IV MB initiated with a first loading dose ( 1 mg/kg over 30 minutes ) then continuous IV infusion( 0.15 mg/kg per hour for up to 24 hours) Terlipressin Group (Group TP) Terlipressin will be initiated with a loading dose ( 2 μg/kg intravenous over 30 minutes ) followed by continuous IV infusion starting by 2 μg/kg/h escalating up every 15 minutes up to 20 μg/kg/h
Neonatal Intensive Care Units (NICUs), Ain Shams University
Cairo, Abbasia, Egypt
RECRUITINGto assess the efficancy of each intervention in improving hemodymaic status: time taken to reach adequate mean blood pressure
The time taken to reach adequate mean blood pressure Reduction in the dosage of the standard inotropic support
Time frame: 24hours
to assess the effect of intervention on survival
mortality rate
Time frame: 4 days
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