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Comparison of adrenaline and noradrenaline for neonates with septic shock

Adrenaline Vs Noradrenaline in neonatal septic shock:A randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027185
Enrollment
60
Registered
2020-08-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R578- Other shock

Interventions

Intervention1: Noradrenaline: After fluid resuscitation is completed neonates with septic shock will receive noradrenaline as per the randomisation table dose being 0.2 microgram per kg,can be given

Sponsors

Bharati Vidyapeeth hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates ( Shock was defined by systemic hypotension (mean blood pressure (i) Tachycardia (heart rate > 20 above baseline ) (ii) Peripheral pulses (iii) Modified extremities colouration (iv) Prolonged capillary refill time >3 sec and; (v) Urine output <1 mL/kg/h

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
1. Response at 1 hour (Resolved/Unresolved) Resolution of shock will be defined at 1 hour as a) Systolic Blood pressure (SBP) as well as Diastolic Blood Pressure (DBP) 5th centile. b) Capillary Refill Time (CFT) 3 s 2. Mortality: Incidence of mortality in both groupsTimepoint: 1 hour for resolution of shock Mortality at discharge from hospital

Secondary

MeasureTime frame
1. Requirement of additional vasopressors.2. Hemodynamic stability requiring no further escalation of vasopressors for a period of ââ?°Â¥ 120 min 3. Vitals (HR, SBP, DBP and MAP) and acid-base parameters 4. Incidence of Complications until discharge i.e. a) Intraventricular Hemorrhage (IVH): b) PVL (Periventricular Leukomalacia) c) Acute Kidney Injury (AKI) d). Necrotizing Enterocolitis (NEC) stage II/ III: e) Duration of days of ventilationTimepoint: Abg at 0 and 60 ââ?¬Ë?mins

Countries

India

Contacts

Public ContactReema A Garegrat

Bharati Vidyapeeth,Pune

drpradeepsuryawanshi@gmail.com9819588972

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026