Health Condition 1: P298- Other cardiovascular disorders originating in the perinatal period
Conditions
Interventions
Intervention1: Physiology oriented echocardiography targeted shock management: Eligible neonates would be assessed with point of care echocardiography (POCE) for screening for duct dependent heart dis
Sponsors
Vishal Sidana
Dr S Venkataseshan
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
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 hypoxic-ischemic encephalopathy (as per a gestational age-appropriate neurological examination system)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reversal of shock Timepoint: 6 hours from randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Systolic dysfunction at the first as well as any of the POCE examinations b) Diastolic dysfunction at the first as well as any of the POCE examinations c) Combined systolic and diastolic dysfunction at the first as well as any of the POCE examinations d) Recovery from shock by 6 hours from randomization e) Recovery from shock by 24 hours from randomization f) Time to reversal of shock (in hours) g) Death or shock reversal during hospital stay h) Refractory shock by 6 hours i) Mortality (all-cause) by 24 hours from randomization j) Mortality (all-cause) by 7 days from randomization k) Mortality (all-cause) during hospital stay l) Culture positive or clinical sepsis within 7 days from randomization m) Exiting the experimental algorithm n) Conducting point of care echocardiography at every action point o) Time taken for conducting/performing POCE p) Adverse events while performing POCE demanding aborting the procedure q) Adverse events while conducting/performing POCE Timepoint: 6 hours, 24 hours, 7 days, 14 days from randomisation and at discharge | — |
Countries
India
Contacts
Public ContactDr S Venkataseshan
Postgraduate Institute of Medical Education and Research (PGIMER)
Outcome results
None listed