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
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.
Investigators
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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