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Clinical Trials/CTRI/2023/08/056672
CTRI/2023/08/056672
Not Yet Recruiting
N/A

Functional echocardiographyfor management of shock in neonates- A randomized controlled trial - NI

Government medical College and Hospital sector 32 Chandigarh0 sites0 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Government medical College and Hospital sector 32 Chandigarh
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Government medical College and Hospital sector 32 Chandigarh

Eligibility 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 \< 5th
  • percentile for gestation or mean blood pressure \< 30 mm of Hg)
  • 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

Outcomes

Primary Outcomes

Not specified

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