Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS

June 2, 2025 updated by: The Second Affiliated Hospital of Chongqing Medical University

Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for Neonatal Acute Respiratory Distress Syndrome

  1. A predictive model for NARDS was established based on perinatal risk factors. Multivariate Logistic regression analysis was used to screen the independent prenatal risk factors for NARDS. A Logistic regression model was constructed using the above independent risk factors and quantified in a nomogram to construct a visualization model for prenatal prediction of NARDS.
  2. The role of ACS in the prevention and treatment of ARDS in near-term/full-term infants.

For neonates with a probability greater than 80% in the prediction model of ARDS, at least one ACS was given before the termination of pregnancy. The GC level of cord blood (taken at birth) and the mRNA levels of α-ENaC, Na-K-atpase and SGK1 in nasal epithelium were measured within 2 hours and 1 day after birth in the ACS intervention group and the control group. The occurrence and severity of pulmonary edema, the occurrence and severity of ARDS, and the mortality rate of NARDS were evaluated by lung ultrasound. The indexes of the two groups were compared horizontally and longitudinally.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Based on the proposed scientific hypothesis, the project team intends to achieve the following research objectives through scientific experiments:

To explore the role of ACS in promoting fetal lung maturation from the perspective of lung fluid clearance through the traditional concept that ACS promotes fetal lung maturation mainly by inducing PS, so as to further expand the object and scope of ACS application.

The prenatal prediction model of ARDS was established by using perinatal risk factors, and the predictive value was visualized.

To explore the clinical value and mechanism of ACS in pregnant women at high risk of NARDS, and to open up new ideas for the prevention and treatment of NARDS from the perspective of promoting lung fluid clearance; The early prevention and treatment strategy of NARDS was established by combining the "prenatal prediction model +ACS", and its effect was evaluated.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

A predictive model for neonatal acute respiratory distress syndrome was established based on perinatal risk factors.

Inclusion Criteria:

  1. The pregnant women with a probability greater than 80% in the prediction model of neonatal acute respiratory distress syndrome and agreed to ACS intervention.
  2. Obtaining patient consent.

Exclusion Criteria:

  1. the pregnant women with a probability of less than 80% in the neonatal acute respiratory distress syndrome prediction model.
  2. The patient refuses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the experimental group
For pregnant women with a probability greater than 80% in the prediction model of NARDS, those who agreed to ACS intervention were included in the experimental group
Drug: Dexamethasone
ACS intervention were used in the experimental group
Other Names:
  • antenatal corticosteroids
No Intervention: the control group
For pregnant women with a probability greater than 80% in the prediction model of NARDS, those who did not agree with ACS intervention were included in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence and severity of neonatal acute respiratory distress syndrome
Time Frame: 1 year
The incidence and severity of neonatal acute respiratory distress syndrome will be compared between the two groups
1 year
The incidence and severity of pulmonary edema
Time Frame: 1 year
The incidence and severity of pulmonary edema will be compared between the two groups
1 year
The mortality of NARDS
Time Frame: 1 year
The mortality rate of NARDS will be compared between the two groups
1 year
The mRNA levels of α-ENaC, Na-K-atpase, and SGK1 in nasal epithelium
Time Frame: Day 0 after birth
The mRNA levels of α-ENaC, Na-K-atpase, and SGK1 in nasal epithelium will be compared between the two groups
Day 0 after birth
The glucocorticoid level in cord blood
Time Frame: Day 0 after birth
The glucocorticoid levels of cord blood will be compared between the two groups
Day 0 after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Collaborators

Children's Hospital of Chongqing Medical University
Chongqing Medical Center for Women and Children
University-Town Hospital of Chongqing Medical University

Investigators

  • Study Chair: Li Wang, MD,PhD, The Second Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

January 1, 2024

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LWang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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