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Clinical Trials/NCT05224921
NCT05224921
Completed
Not Applicable

Study of Peripherel Perfusion Index to Predict Late Onset Sepsis in Very Low Birth Weight Infants

Children's Hospital of Fudan University1 site in 1 country216 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
VLBW - Very Low Birth Weight Infant
Sponsor
Children's Hospital of Fudan University
Enrollment
216
Locations
1
Primary Endpoint
Incidence of late onset sepsis
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

To explore the predictive value of peripheral perfusion index in late onset sepsis of very low birth weight infants , obtain the threshold by observing the perfusion index of very low birth-weight infants within one month after birth, this value can be used as a threshold to predict late onset sepsis in very low birth weight infants.

Detailed Description

From the day the very low birth weight infant was admitted to hospital, monitoring was recorded once a day, and continuous monitoring was recorded for 1 month. Before collection, the infant was confirmed to be in supine position with neutral temperature, and at the same time, the infant was in a quiet state, without the contact and operation of medical personnel. This study will first use LMS curve to fit the trend of perfusion index in very low birth weight infants within one month after birth.The perfusion index threshold of the outcome index was determined by ROC curve.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Infants weighting \<1500g
  • Infants admitted to Children's Hospital of Fudan University

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence of late onset sepsis

Time Frame: From admission into the ward to one month after birth

Neonatal infection occurring 7 days after birth, confirmed by a doctor through laboratory positive indicators or clinical diagnosis

Study Sites (1)

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