Skip to content

Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06188195
Enrollment
500
Registered
2024-01-03
Start date
2024-02-01
Completion date
2025-12-31
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Respiratory Distress Syndrome, Acute

Keywords

Neonatal Acute Respiratory Distress Syndrome, Prediction nomogram, antenatal corticosteroids

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.

Interventions

DRUGDexamethasone

ACS intervention were used in the experimental group

Sponsors

University-Town Hospital of Chongqing Medical University
CollaboratorOTHER
Children's Hospital of Chongqing Medical University
CollaboratorOTHER
Chongqing Medical Center for Women and Children
CollaboratorOTHER
The Second Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence and severity of neonatal acute respiratory distress syndrome1 yearThe incidence and severity of neonatal acute respiratory distress syndrome will be compared between the two groups
The incidence and severity of pulmonary edema1 yearThe incidence and severity of pulmonary edema will be compared between the two groups
The mortality of NARDS1 yearThe mortality rate of NARDS will be compared between the two groups
The mRNA levels of α-ENaC, Na-K-atpase, and SGK1 in nasal epitheliumDay 0 after birthThe 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 bloodDay 0 after birthThe glucocorticoid levels of cord blood will be compared between the two groups

Countries

China

Contacts

Primary ContactLi Wang, MD,PhD
liwang8771@126.com13527499258

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026