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

VLBW - Very Low Birth Weight Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05224921
• Other study ID #: 2021-454
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Hours to 3 Days

Eligibility

Inclusion Criteria:

• Infants weighting <1500g

• Infants admitted to Children's Hospital of Fudan University

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Sepsis
• VLBW - Very Low Birth Weight Infant

Intervention

Other:
• Not applicable (cohort study)
This is a prospective observational study and does not include interventions. The exposure is peripheral perfusion index and the outcome is the incidence of late onset sepsis. From the day when the very low birth weight infant is admitted into hospital, PPI monitoring should be recorded once a day, and continuous monitoring would be recorded until 1 month after birth. Before collection, the infant will be confirmed to be in supine position with neutral temperature, and at the same time, the infant will be in a quiet state, without the contact and operation of medical personnel.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of late onset sepsis	Neonatal infection occurring 7 days after birth, confirmed by a doctor through laboratory positive indicators or clinical diagnosis	From admission into the ward to one month after birth