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

February 3, 2023 updated by: Children's Hospital of Fudan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 3 days (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Infant's birth weight <1500g

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Very low birth weight infants
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From admission into the ward to one month after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2022

Primary Completion (ACTUAL)

November 30, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

January 25, 2022

First Posted (ACTUAL)

February 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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