Prenatal prevention and treatment strategy for neonatal ARDS

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

We will test whether giving antenatal corticosteroids to pregnant women who are predicted to be at high risk of neonatal ARDS can reduce newborn lung fluid problems, ARDS severity, and death.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sex: Female
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University (Academic / other)
• Locations: 1 site (Chongqing)
• Trial ID: NCT06188195 on ClinicalTrials.gov

What this trial studies

Researchers built a prenatal prediction model using multivariable logistic regression and presented it as a nomogram to identify pregnancies at high risk for neonatal ARDS. Pregnant women with a predicted risk greater than 80% who consent will receive at least one dose of dexamethasone before delivery, with a comparison group not receiving the intervention. Cord blood glucocorticoid levels and mRNA expression of α-ENaC, Na-K-ATPase, and SGK1 in neonatal nasal epithelium will be measured within 2 hours and at 24 hours after birth, and lung ultrasound will be used to document pulmonary edema, ARDS occurrence and severity, and mortality. The project links molecular markers of lung fluid clearance with clinical outcomes to see if targeted antenatal steroid use can prevent or lessen NARDS in near-term and full-term infants.

Who should consider this trial

Good fit: Pregnant women at near-term or full-term whose pregnancies have a >80% predicted probability of neonatal ARDS by the nomogram and who agree to antenatal corticosteroid treatment.

Not a fit: Pregnant women with a predicted risk below 80%, those who decline corticosteroids, or those with contraindications to steroids are unlikely to receive benefit from this strategy.

Why it matters

Potential benefit: If successful, targeted antenatal steroid use could lower the incidence and severity of neonatal ARDS and reduce newborn lung-related complications and deaths.

How similar studies have performed: Antenatal corticosteroids are well established to speed lung maturation in preterm infants, but using them to prevent neonatal ARDS in near-term or full-term infants by promoting lung fluid clearance is a relatively novel approach that is not yet widely proven.

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.

Where this trial is running

Chongqing

• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, China (Recruiting)

Study contacts

• Study coordinator: Li Wang, MD,PhD

Conditions Acute Respiratory Distress Syndrome; Respiratory Distress Syndrome, Acute; Neonatal Acute Respiratory Distress Syndrome; Prediction nomogram; antenatal corticosteroids