Predictive Value of PS Application in Premature Infants W... | NCT05772247

Studies
Predictive Value of PS Application in Premature Infants With RDS

NCT05772247

Sponsor

The First Hospital of Jilin University

Status

Unknown status

Last Update Posted

Mar 16, 2023Actual

Enrollment

1,392Estimated

Phase

Not provided

Conditions

Respiratory Distress Syndrome

Interventions

Lung ultrasound

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Estimated

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Feb 12, 2023

First Submission Date that Met QC Criteria

Mar 15, 2023

First Posted Date

Mar 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2023

Last Update Posted Date

Mar 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,392Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PS application			Diagnostic Test: Lung ultrasound
non-PS application			Diagnostic Test: Lung ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lung ultrasound	Diagnostic Test	Lung ultrasound score was calculated by the results of lung ultrasound examination	PS application non-PS application

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

1 Month

Standard Ages

Child

Study Population

Preterm infants <37 weeks gestational age

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided