Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorThe Second Affiliated Hospital of Chongqing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

The patient refuses.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Drug

    ACS intervention were used in the experimental group

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: the experimental groupExperimental treatment 1 intervention
Group B: the control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The incidence and severity of neonatal acute respiratory distress syndrome

The incidence and severity of neonatal acute respiratory distress syndrome will be compared between the two groups

Time frame
1 year
2

The incidence and severity of pulmonary edema

The incidence and severity of pulmonary edema will be compared between the two groups

Time frame
1 year
3

The mortality of NARDS

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

Time frame
1 year
4

The mRNA levels of α-ENaC, Na-K-atpase, and SGK1 in nasal epithelium

The mRNA levels of α-ENaC, Na-K-atpase, and SGK1 in nasal epithelium will be compared between the two groups

Time frame
Day 0 after birth

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Second Affiliated Hospital of Chongqing Medical University

Lead sponsor

University-Town Hospital of Chongqing Medical University

Collaborator

Children's Hospital of Chongqing Medical University

Collaborator

Chongqing Medical Center for Women and Children

Collaborator