NCT05772247

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,392

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 16, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

February 12, 2023

Last Update Submit

March 15, 2023

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • Whether the patient uses ps (pulmonary surfactant)

    The standards used by PS are based on the European consensus

    2023.2-2023.12

Study Arms (2)

PS application

Diagnostic Test: Lung ultrasound

non-PS application

Diagnostic Test: Lung ultrasound

Interventions

Lung ultrasoundDIAGNOSTIC_TEST

Lung ultrasound score was calculated by the results of lung ultrasound examination

PS applicationnon-PS application

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preterm infants \<37 weeks gestational age

You may qualify if:

  • Hospital admission within 2 hours after birth;
  • The diagnosis was RDS;
  • Parents agree to attend

You may not qualify if:

  • chromosomal abnormalities or complex congenital malformations;
  • congenital pulmonary disease;
  • severe sepsis, disseminated intravascular coagulation, septic shock and other critical conditions;
  • LUS and blood gas analysis have been examined before the application of alveolar surfactant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

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

Study Record Dates

First Submitted

February 12, 2023

First Posted

March 16, 2023

Study Start

April 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 16, 2023

Record last verified: 2023-02