Health Condition 1: P298- Other cardiovascular disorders originating in the perinatal period
Conditions
Interventions
Intervention1: Norepinephrine infusion: The study nurse will dilute 0.3 ml/kg norepinephrine in 10 ml D5 solution and initiate infusion at 0.4 mL/h (0.2 μg/kg/min). The intervention drug will be give
Sponsors
All India Institute of Medical Sciences, Rishikesh
Mayank Priyadarshi
Eligibility
Inclusion criteria
Inclusion criteria: All neonates (term and preterm) with fluid refractory septic shock admitted in the NICU will be included. Terms neonates will be included until day 28 of life. Preterm neonates will be included till 40 weeks post menstrual age.
Exclusion criteria
Exclusion criteria: Major congenital anomaly Moderate to severe HIE till first 72 hours of life Diagnosed congenital heart disease Already on inotropes Post-operative patients developing shock in the first 24 hours of surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of shock reversal. Shock reversal shall be defined as presence of both: 1. Correction of hypotension: SBP, DBP and MAP more than third centile 2. Clinical end-points (any two): a) Capillary refill less than or equal to 2 seconds b) Normal pulses with no difference in quality between peripheral and central pulses c) Warm extremitiesTimepoint: During hospital stay | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change in cerebral tissue oxygen saturation (crSO2) at 30-60 minutes and 6 hours after initiation vasopressor support â?¢ Need for further escalation of vasoactive drugs for a period of â?¥ 120 min thereafter â?¢ Time to reversal of shock â?¢ Requirement of additional vasoactive drugs/ hydrocortisone â?¢ Lactate clearance at 6-8 hours and 24 hours after initiation of vasopressor support â?¢ Incidences of hyperglycemia, tachyarrhythmia and sinus tachycardia â?¥200/min â?¢ Need and duration of respiratory support â?¢ Change in the following acid base parameters at baseline and at 24 hours after diagnosis of shock: pH, bicarbonate, base excess, lactate â?¢ Incidence of morbidities, i.e., Intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) stage II/III and retinopathy of prematurity (ROP) any stage until hospital discharge â?¢ Final outcome Timepoint: During hospital stay | — |
Countries
India
Contacts
Public ContactMayank Priyadarshi
AIIMS Rishikesh
Outcome results
None listed