Pentoxifylline for sepsis in newborns

Phase 2

• Conditions: Health Condition 1: P368- Other bacterial sepsis of newborn

• Registration Number: CTRI/2023/01/048665
• Lead Sponsor: Dr Deepak Chawla

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 [ <36.5°C], hyperthermia [ >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 ( <45 mg/dl) or hyperglycemia ( >140 mg/dl)

â?? 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

Neonates with any of the following conditions will be excluded

• IVH (grade 3 or 4)

• Major congenital malformation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The survival of the neonate with an nSOFA score of 0Timepoint: 7th day of enrolment

Secondary Outcome Measures

Name	Time	Method
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 <br/ ><br>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 itâ??s componentsTimepoint: At 7, 10 and 14 days of enrolment