Health Condition 1: P368- Other bacterial sepsis of newborn
Conditions
Interventions
Intervention1: Pentoxifylline: Neonates in the intervention group will receive Pentoxifylline at a dose of 5mg/kg/hour over 6 hours for 5 consecutive days.
Control Intervention1: Placebo: Neonates in
Sponsors
Dr Deepak Chawla
Eligibility
Inclusion criteria
Inclusion criteria: 1. New onset of at least two of the following signs after 12 hours of birth AND decision of the clinical care team to start or upgrade antibiotics: -Temperature instability (hypothermia [ 38°C], core- periphery temperature difference >2°C) -Respiratory signs (tachypnea, grunting, intercostal/ subcostal retractions, apnea, cyanosis) -Gastrointestinal signs (feeding intolerance, abdominal distension, altered aspirates, radiological signs) -Neurologic signs (encephalopathy, hypotonia, lethargy, seizures) -Unexplained metabolic acidosis (BE > -10) -Hypoglycemia ( 140 mg/dl) – Increased oxygen requirement or ventilatory support OR 2. Any one of the following AND decision of the clinical care team to start or upgrade antibiotics: -Sclerema -Shock needing inotropic support -Positive blood or CSF culture
Exclusion criteria
Exclusion criteria: Neonates with any of the following conditions will be excluded • IVH (grade 3 or 4) • Major congenital malformation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The survival of the neonate with an nSOFA score of 0Timepoint: 7th day of enrolment | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse outcomes directly attributable to Pentoxifylline (thrombocytopenia [1 lac/cumm], increased gastric residue, vomiting, cholestatic jaundice requiring therapy)Timepoint: During intervention;All cause mortalityTimepoint: Till hospital stay A sensitivity analysis will be done excluding the first 24 hour after enrolment;Duration and type of antibiotics therapyTimepoint: During the episode of sepsis and during hospital stay;Duration and types of inotropic supportTimepoint: During the episode of sepsis and during hospital stay;Duration of assisted ventilation (invasive and non invasive)Timepoint: Till hospital stay;Duration of hospital stayTimepoint: Till discharge from hospital;Need to upgrade antibioticsTimepoint: Till hospital stay;nSOFA score and it’s componentsTimepoint: At 7, 10 and 14 days of enrolment | — |
Countries
India
Contacts
Public ContactDr Deepak Chawla
Government medical college and hospital
Outcome results
None listed