Comparing Adrenaline, Noradrenaline, and Dopamine in Newborn Septic Shock

Low dose adrenaline versus noradrenaline versus dopamine as first line vasoactive therapy in neonatal septic shock: a randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110948

Enrollment

Registered

2026-05-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: I959- Hypotension, unspecified

Interventions

Intervention1: LOW DOSE ADRENALINE VERSUS DOPAMINE AS FIRST LINE VASOACTIVE THERAPY IN NEONATAL SEPTIC SHOCK: 1. Low dose adrenaline group: Starting at 0.02 mcg/kg/min , titrated to 0.1 mcg/kg/min eve

Eligibility

Inclusion criteria

Inclusion criteria: 1. Inborn 2. Neonates with septic shock 3. Clinical sepsis or positive blood culture

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies 2. Known or suspected chromosomal anomalies 3. Severe perinatal asphyxia ( Stage 3 HIE or APGAR less than 3 at 10 minutes ) 4. Clinically suspected or echocardiography proven congenital heart disease 5. Already on any vasoactive infusion at time of enrollment 6. Outborn baby 8. Refused consent.

Design outcomes

Primary

Measure	Time frame
Proportion of neonates achieving sustained hemodynamic stabilizationTimepoint: At 1 hour after initiation of vasoactive therapy	—

Secondary

Measure	Time frame
1. Proportion of neonates requiring addition of a second vasoactive agent 2.Time to reversal of shock from start of vasoactive infusion 3. Measurement of SVC flow at baseline, 6 hours and at 24 hours after diagnosis of shock 4. PI at baseline, 6 hours and at 24 hours after diagnosis of shock. 5. Measurement of arterial lactate at baseline, 6 hours and at 24 hours after diagnosis of shock. 6. Duration of vasoactive therapy 7. Duration of respiratory support 8. Intraventricular hemorrhage, grade 3 and above on cranial ultrasound 9. Incidence of necrotising enterocolitis ( Modified Bell Staging II and above) 10. Incidence of acute kidney injury 11. Incidence of tachyarrhythmia 12. Incidence of hyperglycemia within first 12 hours 13. Retinopathy of prematurity 14. Total duration of NICU stay 15. Total duration of hospitalisation 16. Death ( all causes) before dischargeTimepoint: During hospital stay	—

Measure

Time frame

1. Proportion of neonates requiring addition of a second vasoactive agent 2.Time to reversal of shock from start of vasoactive infusion 3. Measurement of SVC flow at baseline, 6 hours and at 24 hours after diagnosis of shock 4. PI at baseline, 6 hours and at 24 hours after diagnosis of shock. 5. Measurement of arterial lactate at baseline, 6 hours and at 24 hours after diagnosis of shock. 6. Duration of vasoactive therapy 7. Duration of respiratory support 8. Intraventricular hemorrhage, grade 3 and above on cranial ultrasound 9. Incidence of necrotising enterocolitis ( Modified Bell Staging II and above) 10. Incidence of acute kidney injury 11. Incidence of tachyarrhythmia 12. Incidence of hyperglycemia within first 12 hours 13. Retinopathy of prematurity 14. Total duration of NICU stay 15. Total duration of hospitalisation 16. Death ( all causes) before dischargeTimepoint: During hospital stay

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Countries

India

Contacts

Public ContactDr Madhurima Ganguly

IPGMER and SSKM Hospital

bijansaha18@gmail.com9051389120

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026