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Efficacy and Safety of Drugs which Improve Blood Pressure in Newborns with Shock

Efficacy and Safety of Vasopressin versus Dopamine as First Line Therapy in Neonatal Shock: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035802
Enrollment
200
Registered
2021-08-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: P969- Condition originating in the perinatal period, unspecified

Interventions

Intervention1: Vasopressin: Vasopressin to be administered in escalating doses, starting from 0.3mU per kg per minute, increased every 30 minutes, if no response to a maximum of 0.6 mU per kg per minu

Sponsors

Banaras Hindu University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Shock will be defined by the presence of two or more of the following criteria: 1. Heart rate above 180 per minute 2. Capillary refill time more than 3 seconds 3. Skin mottling 4. Cold extremities 5. Feeble peripheral pulses 6. Altered sensorium 7. Hypotension as per nomogram 8. Oliguria 9. Blood lactate above 4 mmol per litre

Exclusion criteria

Exclusion criteria: 1. Life threatening congenital malformations 2. Considered nonviable by the treating clinician 3. Prior exposure to inotropes 4. Failure to obtain consent

Design outcomes

Primary

MeasureTime frame
Treatment failure will be defined as persistence of shock after 2 hours of starting vasopressors in escalating dosagesTimepoint: 2 hours

Secondary

MeasureTime frame
Changes in parameters at various time points during hospitalization: 1. Heart rate 2. Blood pressure, systolic, disatolic, mean 3. Oxygen saturation 4. Blood lactate 5 Arterial blood gases 6. Blood glucose 7. Serum sodium 8. Blood urea and serum creatinine 9. Respiratory support 10. Vasoactive inotropic score 11. Hospital mortality 12. Duration of hospital stayTimepoint: 1. For secondary outcome variables 1 to 10, during acute phase of illness 2. For hospital mortality, during birth hospitalization. 3. Duration of hospital stay during birth hospitalization

Countries

India

Contacts

Public ContactShikhar Garg

Banaras Hindu University

ashokkumar_bhu@hotmail.com09415300370

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026