Prenatal prevention and treatment strategy for neonatal ARDS
Official title: Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for Neonatal Acute Respiratory Distress Syndrome
Run by The Second Affiliated Hospital of Chongqing Medical University · NCT06188195 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 500 (estimated) |
| Sponsor | The Second Affiliated Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | June 4, 2025 |
| Trial ID | NCT06188195 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China Recruiting
Study contacts
- Study coordinator: Li Wang, MD,PhD
- Email: liwang8771@126.com
- Phone: 13527499258
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.