Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS

Not Applicable

Not yet recruiting

• Conditions: Acute Respiratory Distress Syndrome; Respiratory Distress Syndrome, Acute
• Interventions: Drug: Dexamethasone

• Registration Number: NCT06188195
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief Summary

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.

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 Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2024-01-01
• Study First Posted: 2024-01-03
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26
• Study Start: 2024-02-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the experimental group	Dexamethasone	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

Primary Outcome Measures

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