Peripherel Perfusion Index to Predict Sepsis in Very Low Birth Weight Infants

Completed

• Conditions: VLBW - Very Low Birth Weight Infant
• Interventions: Other: Not applicable (cohort study)

• Registration Number: NCT05224921
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-02-04
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Very low birth weight infants	Not applicable (cohort study)	Include very low birth weight infants admitted into NICU in Children's hospital of Fudan University, and prospectively observe whether they get late onset sepsis.

Primary Outcome Measures

Name	Time	Method
Incidence of late onset sepsis	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

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China