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

• Sponsor: University-Town Hospital of Chongqing Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05647850
• Collaborator: (none)
• Enrollment: 2,000
• Anticipated Duration (Months): 36

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neonatology	Other: No intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2000 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Optimization and Clinical Study of Early Prediction Model for Neonatal Acute Respiratory Distress Syndrome
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Baseline characteristics of all patients	Other: No intervention; No intervention
General characteristics of the patients.	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures

1. General characteristics of the patients [2023.1-2025.12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Minute and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University-Town Hospital of Chongqing Medical University

Investigators

• Principal Investigator: Hui Liu, University-Town Hospital of Chongqing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hui Liu, Attending physician, University-Town Hospital of Chongqing Medical University
• ClinicalTrials.gov Identifier: NCT05647850
• Other Study ID Numbers: 123456
• First Posted: Dec 13, 2022
• Last Update Posted: Dec 14, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hui Liu, Attending physician, University-Town Hospital of Chongqing Medical University: Neonatal acute respiratory distress syndrome; Model of prediction; Perinatal factors
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury

Study Results

No Results Posted as of Dec 14, 2022