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NCT05772247 Clinical Trial

Predictive Value of PS Application in Premature Infants With RDS

Respiratory Distress Syndrome Clinical Trial

Official title:
Predictive Value of PS Application in Premature Infants With RDS by Different Pulmonary Ultrasound Scores: a Prospective Multicenter Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05772247
Other study ID # FirstJilinU2
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date December 31, 2023

Study information
Verified date February 2023
Source The First Hospital of Jilin University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A multicenter prospective study was conducted to compare the predictive value of 6-zone, 10-zone, and 12-zone LUS scores for PS application in early and late preterm infants.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1392
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Day to 1 Month
Eligibility Inclusion Criteria: 1. Hospital admission within 2 hours after birth; 2. The diagnosis was RDS; 3. Parents agree to attend Exclusion Criteria: 1. chromosomal abnormalities or complex congenital malformations; 2. congenital pulmonary disease; 3. severe sepsis, disseminated intravascular coagulation, septic shock and other critical conditions; 4. LUS and blood gas analysis have been examined before the application of alveolar surfactant.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Lung ultrasound
Lung ultrasound score was calculated by the results of lung ultrasound examination

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The First Hospital of Jilin University

Outcome
Type Measure Description Time frame Safety issue
Primary Whether the patient uses ps (pulmonary surfactant) The standards used by PS are based on the European consensus 2023.2-2023.12
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