Clinical trial

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

Name
LWang
Description
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.
Trial arms
Trial start
2024-02-01
Estimated PCD
2024-12-31
Trial end
2025-12-31
Status
Not yet recruiting
Treatment
Dexamethasone
ACS intervention were used in the experimental group
Arms:
the experimental group
Other names:
antenatal corticosteroids
Size
500
Primary endpoint
The incidence and severity of neonatal acute respiratory distress syndrome
1 year
The incidence and severity of pulmonary edema
1 year
The mortality of NARDS
1 year
The mRNA levels of α-ENaC, Na-K-atpase, and SGK1 in nasal epithelium
Day 0 after birth
The glucocorticoid level in cord blood
Day 0 after birth
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}
Updated at
2024-01-26

1 organization

1 product

3 indications

Indication
Acute