Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere
Conditions
Interventions
Intervention1: Physiology based echocardiography integrated algorithm: Once the initial management of initiating a 0.9% saline bolus at 10 ml/kg to be administered over 30-60 minutes duration through
Sponsors
Venkataseshan Sundaram
Eligibility
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery from shockTimepoint: 6 hours from randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactVenkataseshan Sundaram
Postgraduate Institute of Medical Education and Research
Outcome results
None listed