Health Condition 1: I95- Hypotension
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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 percentile for gestation or mean blood pressure CRT > 3 s Perfusion index Central- to-peripheral temperature difference > 2°C Oliguria Metabolic acidosis (base excess 5 mMol/L)
Exclusion criteria
Exclusion criteria: Neonates with any of the following: Major congenital malformations Persistent pulmonary hypertension of newborn Moribund status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival without inotropic support at 72 hours of randomizationTimepoint: 72 hours of randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 normalization of parameters used to define shock & no further requirement of inotropic support for the next 120 minutes 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. | — |
Countries
India
Contacts
Government medical College and Hospital sector 32 Chandigarh