A comparative study between two groups of randomly chosen newborn babies to see the effects of hydrocortisone in shock when given early (along with first line vasopressor agents) versus standard timing (failure of vasopressor drugs to maintain blood pressure).
Phase 4
Completed
- Conditions
- Health Condition 1: null- Neonates with shock
- Registration Number
- CTRI/2016/09/007276
- Lead Sponsor
- Sankalp Dudeja
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
Inclusion Criteria
Any neonate less than 44 weeks post-menstural age, presenting with clinical shock.
Exclusion Criteria
a) Clinical setting of dehydration/ obvious blood loss
b) Hypoxic ischemic encephalopathy- moderate to severe
c) Suspected or proven duct dependent systemic/pulmonary circulation
d) Neonates received postnatal steroids in the past 7 days
e) Suspected or proven congenital adrenal hyperplasia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All cause mortalityTimepoint: Within 14 days of onset of shock.
- Secondary Outcome Measures
Name Time Method Abdominal distension, Altered aspirates, hematemesis, hyperglycemia or hypertensionTimepoint: Within 72 hours of drug administration;Functional echocardiographic markers of systolic and diastolic functions viz left ventricular systolic functions (Cardiac output, Ejection Fraction, Fractional Shortening, End Systolic Wall Stress (ESWS), Heart Rate corrected velocity of circumferential fiber shortening (VCFc), E:A ratio, and IVRT)Timepoint: At baseline (Preferably before initiation of vasopressor drugs or within one hour of their initiation) and 4-6 hours after giving trial drug.;Incidence of Catecholamine resistant shockTimepoint: During that episode of shock;Incidence of definite NEC, ROP, BPD and PVLTimepoint: During the hospital stay;Inotrope score and duration of inotropes/ vasopressorsTimepoint: During that episode of shock