Comparison of Functional echocardiographic and Clinical parameters with Clinical parameters only for management of shock in neonates.
Not Applicable
- Conditions
- Health Condition 1: I95- Hypotension
- Registration Number
- CTRI/2023/08/056672
- Lead Sponsor
- Government medical College and Hospital sector 32 Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All inborn neonates born at > 27 completed weeks of gestation and who develop clinical signs of shock. The shock will be defined as the presence of at least 2 of the following 7 criteria:
Heart rate > 180 per minute
Decrease in blood pressure (systolic, diastolic, or mean blood pressure < 5th
percentile for gestation or mean blood pressure < 30 mm of Hg)
CRT > 3 s
Perfusion index <0.44
Central- to-peripheral temperature difference > 2°C
Oliguria < 0.5 ml/kg/h during the preceding 6 h
Metabolic acidosis (base excess < -5 or lactate > 5 mMol/L)
Exclusion Criteria
Neonates with any of the following:
Major congenital malformations
Persistent pulmonary hypertension of newborn
Moribund status
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival without inotropic support at 72 hours of randomizationTimepoint: 72 hours of randomization
- Secondary Outcome Measures
Name Time Method Duration of NICU stayTimepoint: time of transfer out of nicu;Incidence of abnormal cranial USG (severe IVH or cystic PVL) at dischargeTimepoint: discharge;Survival till dischargeTimepoint: discharge;Time to hemodynamic stability - defined as the time from randomization to <br/ ><br>normalization of parameters used to define shock & no further requirement of <br/ ><br>inotropic support for the next 120 minutes <br/ ><br>Timepoint: Time point since allocation when baby has been on stable inotropic or No inotropic support for at least 120 minutes while there are no abnormal parameters which were used to define shock.