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NCT Number: NCT06188195

Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Acute Respiratory Tract Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location status: Recruiting

Location contact

Li Wang

CONTACT

[email protected]

13527499258

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Dexamethasone

Drug

ACS intervention were used in the experimental group

Other names: antenatal corticosteroids

Primary outcomes

  1. 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

  2. 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

  3. The mortality of NARDS

    Time frame: 1 year

    The mortality rate of NARDS will be compared between the two groups

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Li Wang, MD,PhD

CONTACT

[email protected]

13527499258

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2024
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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