Predictive Value of PS Application in Premature Infants With RDS

• Sponsor: The First Hospital of Jilin University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05772247
• Collaborator: (none)
• Enrollment: 1,392
• Anticipated Duration (Months): 9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome	Diagnostic Test: Lung ultrasound

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1392 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Predictive Value of PS Application in Premature Infants With RDS by Different Pulmonary Ultrasound Scores: a Prospective Multicenter Study
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Whether the patient uses ps (pulmonary surfactant) [2023.2-2023.12]

   The standards used by PS are based on the European consensus

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 1 Month
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• The First Hospital of Jilin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Hospital of Jilin University
• ClinicalTrials.gov Identifier: NCT05772247
• Other Study ID Numbers: FirstJilinU2
• First Posted: Mar 16, 2023
• Last Update Posted: Mar 16, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn

Study Results

No Results Posted as of Mar 16, 2023