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Clinical Trials/CTRI/2024/04/066566
CTRI/2024/04/066566
Not yet recruiting
未知

An open label randomized controlled trial to assess the role of serial physical examination for asymptomatic neonates = 35 weeks gestation at risk of early onset sepsis - SPEAR

ONE0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
ONE
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
ONE

Eligibility Criteria

Inclusion Criteria

  • All newborns greater than equal to 35 weeks but less than 42 weeks gestation born at AIIMS Nagpur, who are well appearing at birth and are at risk of early onset sepsis, provided they do not meet the exclusion criteria (risk factors for early onset sepsis will be defined as per our unit protocol which have been modified from NICE guidelines as mentioned below).

Exclusion Criteria

  • Exclusion criteria
  • a) Parents or guardians unwilling to provide consent for the study.
  • b) All suspected cases of congenital malformations, genetic diseases or chromosomal disorders.
  • c) All neonates who are non\-vigorous at birth, require neonatal resuscitation or are symptomatic for EOS within 1 hour of birth

Outcomes

Primary Outcomes

Not specified

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