Efficacy and Safety of Drugs which Improve Blood Pressure in Newborns with Shock
Not Applicable
Completed
- Conditions
- Health Condition 1: P969- Condition originating in the perinatal period, unspecified
- Registration Number
- CTRI/2021/08/035802
- Lead Sponsor
- Banaras Hindu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
1. Life threatening congenital malformations
2. Considered nonviable by the treating clinician
3. Prior exposure to inotropes
4. Failure to obtain consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment failure will be defined as persistence of shock after 2 hours of starting vasopressors in escalating dosagesTimepoint: 2 hours
- Secondary Outcome Measures
Name Time Method Changes in parameters at various time points during hospitalization: <br/ ><br>1. Heart rate <br/ ><br>2. Blood pressure, systolic, disatolic, mean <br/ ><br>3. Oxygen saturation <br/ ><br>4. Blood lactate <br/ ><br>5 Arterial blood gases <br/ ><br>6. Blood glucose <br/ ><br>7. Serum sodium <br/ ><br>8. Blood urea and serum creatinine <br/ ><br>9. Respiratory support <br/ ><br>10. Vasoactive inotropic score <br/ ><br>11. Hospital mortality <br/ ><br>12. Duration of hospital stayTimepoint: 1. For secondary outcome variables 1 to 10, during acute phase of illness <br/ ><br>2. For hospital mortality, during birth hospitalization. <br/ ><br>3. Duration of hospital stay during birth hospitalization