Randomized Controlled Trial Comparing Low Dose Adrenaline and Dopamine in Fluid Refractory Septic Shock among Preterm Neonate

Comparative efficacy of low dose adrenaline versus dopamine in fluid refractory septic shock among preterm neonates: A Randomised Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110914

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 in fluid refractory septic shock: The enrolled neonates will be randomized to receive either low dose adrenaline or dopamine. The neonates will first receive a fluid

Eligibility

Inclusion criteria

Inclusion criteria: 1. Inborn 2. Gestation age 26 -36 weeks 3. Neonates with fluid refractory septic shock (persisting signs of shock despite adequate fluid resuscitation typically upto 20 ml/kg and 40 ml/kg of isotonic fluid boluses over 1 hour in less than 30 weeks and above respectively requiring vasoactive support to maintain adequate perfusion and blood pressure.)

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies 2. Known/suspected chromosomal anomalies 3. Severe perinatal asphyxia 4. Clinically suspected or echocardiography proven congenital heart disease including hemodynamically significant patent ductus arteriosus 5. Hypovolemic or cardiogenic shock 6. Outborn babies 7. Shock in the first 24 hours after surgery 8. Refused consent.

Design outcomes

Primary

Measure	Time frame
Resolution of shockTimepoint: 1 hour after treatment	—

Secondary

Measure	Time frame
1.Need for additional vasopressors 2. Time to reversal of shock 3.Measurement of arterial lactate at baseline & at 24 hours after diagnosis of shock 4.Measurement of Superior Vena Cava flow cardiac output fractional shortening at baseline 2 hours & at 24 hours after diagnosis of shock 5. Duration of respiratory support 6. Intraventricular haemorrhage grade 3 & above on cranial ultrasound 7.Incidence of necrotising enterocolitis ( Modified Bell Staging II & above) 8.Incidence of acute kidney injury 9.Retinopathy of prematurity 10.Total duration of NICU stay 11.Total duration of hospitalisation 12.Death ( all causes) before discharge Timepoint: At 44 weeks of post menstrual age	—

Measure

Time frame

1.Need for additional vasopressors 2. Time to reversal of shock 3.Measurement of arterial lactate at baseline & at 24 hours after diagnosis of shock 4.Measurement of Superior Vena Cava flow cardiac output fractional shortening at baseline 2 hours & at 24 hours after diagnosis of shock 5. Duration of respiratory support 6. Intraventricular haemorrhage grade 3 & above on cranial ultrasound 7.Incidence of necrotising enterocolitis ( Modified Bell Staging II & above) 8.Incidence of acute kidney injury 9.Retinopathy of prematurity 10.Total duration of NICU stay 11.Total duration of hospitalisation 12.Death ( all causes) before discharge Timepoint: At 44 weeks of post menstrual age

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Countries

India

Contacts

Public ContactDr Madhurima Ganguly

IPGMER and SSKM Hospital

ratansarmistha2011@gmail.com9433702671

Outcome results

None listed

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