NCT05647850

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2.9 years

First QC Date

November 30, 2022

Last Update Submit

November 6, 2023

Conditions

Neonatology

Keywords

Neonatal acute respiratory distress syndromeModel of predictionPerinatal factors

Outcome Measures

Primary Outcomes (1)

  • General characteristics of the patients

    2023.1-2025.12

Study Arms (2)

Baseline characteristics of all patients

Other: No intervention

General characteristics of the patients.

Other: No intervention

Interventions

No interventionOTHER

No intervention

Baseline characteristics of all patientsGeneral characteristics of the patients.

Eligibility Criteria

Age1 Minute+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • A newborn born alive

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University-Town Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Women and Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Umbilical cord blood was used to test inflammatory markers of Umbilical cord blood.

Study Officials

  • Hui Liu

    University-Town Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Liu

CONTACT

+8615223013501liuhui8805@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 13, 2022

Study Start

January 1, 2023

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)