Comparison of two different algorithms for management of neonatal shock
Not Applicable
- Conditions
- Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere
- Registration Number
- CTRI/2020/11/029301
- Lead Sponsor
- Venkataseshan Sundaram
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Consecutive, inborn neonates of less than or equal to 44 weeks post-menstrual age admitted in the intensive care area for shock irrespective of the etiology of shock
Exclusion Criteria
1) Suspected or proven congenital heart disease which were diagnosed prior to the onset of shock (patent ductus arteriosus of prematurity would not be considered under this list of congenital heart diseases)
2) Major or life threatening congenital malformation
3) Perinatal asphyxia with severe hypoxia-ischemia (as per a gestational age appropriate neurological examination system)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recovery from shockTimepoint: 6 hours from randomisation
- Secondary Outcome Measures
Name Time Method Adverse events while conducting a POCETimepoint: 6 hours from randomisation;All-cause mortalityTimepoint: 24 hours from randomisation;Culture positive or clinical sepsisTimepoint: 7 days from randomisation;Death or reversal from shockTimepoint: During hospital stay;MortalityTimepoint: 7 days from randomisation;Mortality during hospital stayTimepoint: Duration of hospital stay;Need to exit the experimental armTimepoint: 6 hours from randomisation;Proportion were a POCE was conductedTimepoint: 6 hours from randomisation;Refractory shockTimepoint: 6 hours from randomisation;Time taken for conducting a POCETimepoint: in hours;Time to reversal of shockTimepoint: in hours