Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS

Chongqing Medical University

Status: Enrolling

Conditions: Respiratory Distress Syndrome, Acute; Acute Respiratory Distress Syndrome

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT06188195

LWang

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

the experimental group

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

the control group

No Intervention group

Description:

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