Optimization and Clinical Study of Early Prediction Model... | NCT05647850

Studies
Optimization and Clinical Study of Early Prediction Model for Neonatal Acute Respiratory Distress Syndrome

NCT05647850

Sponsor

University-Town Hospital of Chongqing Medical University

Status

Unknown status

Last Update Posted

Nov 7, 2023Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Neonatology

Interventions

No intervention

Countries

China

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Nov 30, 2022

First Submission Date that Met QC Criteria

Nov 30, 2022

First Posted Date

Dec 13, 2022Actual

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

Nov 6, 2023

Last Update Posted Date

Nov 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hui Liu, Attending physician, University-Town Hospital of Chongqing Medical UniversityPrincipal Investigator

Lead Sponsor

University-Town Hospital of Chongqing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The goal of this observational study is to learn about neonatal acute respiratory distress syndrome in describe participant population. The main question it aims to answer is: using perinatal factors to predict early neonatal acute respiratory distress syndrome and reduce its mortality.

Participants' umbilical cord blood will be collected for testing, but will not receive any intervention.

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

Retention

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Baseline characteristics of all patients			Other: No intervention
General characteristics of the patients.			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Baseline characteristics of all patients General characteristics of the patients.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
General characteristics of the patients		2023.1-2025.12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A newborn born alive

Exclusion Criteria:

Stillborn newborn
Respiratory distress syndrome(RDS), transient tachypnoea of the neonate (TTN), or congenital anomalies as a primary current acute respiratory condition
Hereditary endocrine and metabolic diseases
Incomplete records

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All infants from a multi-center study in China, will hospitalise between January 1, 2023 and December 31, 2025.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hui Liu	Contact	+8615223013501		liuhui8805@126.com

Overall Officials

Name	Affiliation	Role
Hui Liu	University-Town Hospital of Chongqing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University-Town Hospital of Chongqing Medical University	Recruiting	Chongqing	Chongqing Municipality	400000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided