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

NCT05224921 | Completed

• 1 other identifier: 2021-454
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

VLBW - Very Low Birth Weight Infant

Keywords

Late onset sepsis; Peripheral perfusion index

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Interventions

Not applicable (cohort study) OTHER

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.

Very low birth weight infants

Eligibility Criteria

• Age: 0 Hours - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infant's birth weight \<1500g

You may qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Interventions

Cohort Studies

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: January 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)