Predictive Value of PS Application in Premature Infants With RDS

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Diagnostic test: Lung ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 1392

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants <37 weeks gestational age

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PS application	Diagnostic test: Lung ultrasound; Lung ultrasound score was calculated by the results of lung ultrasound examination
non-PS application	Diagnostic test: Lung ultrasound; Lung ultrasound score was calculated by the results of lung ultrasound examination

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: FirstJilinU2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No