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Comparison of Functional echocardiographic and Clinical parameters with Clinical parameters only for management of shock in neonates.

Functional echocardiography for management of shock in neonates- A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056672
Enrollment
82
Registered
2023-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: I95- Hypotension

Interventions

Intervention1: Functional Echo: All babies with shock will receive normal saline bolus 10ml /kg at the time of randomisation. Neonates enrolled in the Echo group after the fluid bolus will be assesse
Cardiac output and systemic blood flow
Presence of PDA. The therapy for shock which includes fluid therapy and Inotropes will be guided by both clinical/Lab(Heart rate, Blood pressures, Capillary refill time, Central to peripheral tempera

Sponsors

Government medical College and Hospital sector 32 Chandigarh
Lead Sponsor

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

MeasureTime frame
Survival without inotropic support at 72 hours of randomizationTimepoint: 72 hours of randomization

Secondary

MeasureTime 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

Public ContactDr Yaseer Ahmad Mir

Government medical College and Hospital sector 32 Chandigarh

drdeepak.chawla@gmail.com9646121559

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026