Using Dexamethasone to Help Late Preterm Infants
Antenatal Dexamethasone for Late Preterm Deliveries: a Randomized Controlled Trial
This study is testing if giving a medication called dexamethasone to pregnant women at risk of having late preterm babies can help those babies breathe better and have fewer health problems after birth.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 294 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Chulalongkorn University Academic / other |
| Locations | 1 site (Da Nang) |
| Trial ID | NCT05841121 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of antenatal dexamethasone in reducing respiratory support needs and neonatal complications in late preterm infants. Women with singleton pregnancies at high risk of late preterm delivery will be randomly assigned to receive either dexamethasone or standard care. The study will measure outcomes such as the need for respiratory support, neonatal morbidity, mortality, and length of hospital stay. The trial will involve 300 participants and will be conducted at Danang Hospital for Women.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 45 years with singleton pregnancies between 34 and 36 weeks of gestation who are at high risk for late preterm delivery.
Not a fit: Patients who may not benefit include those with multiple pregnancies, severe fetal malformations, or contraindications to dexamethasone.
Why it matters
Potential benefit: If successful, this approach could significantly reduce respiratory complications and improve outcomes for late preterm infants.
How similar studies have performed: Previous studies have shown that antenatal corticosteroids can improve outcomes for preterm infants, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 34+0/7 to 36+6/7 weeks * Expected preterm delivery for any indications in the next 7 days. Exclusion Criteria: * Fetal death * Severe fetal malformation * Twin or multiple pregnancy * Maternal contraindication to dexamethasone: hypersensitive with steroids, any infection * Severe maternal conditions such as eclampsia, cardiac arrest, antepartum hemorrhage due to placenta previa or abruption * Delivery estimated within 2 hours: total cervical dilation * Received steroids within 1 week
Where this trial is running
Da Nang
- Danang HOspital for Women and Children — Da Nang, Vietnam (Recruiting)
Study contacts
- Study coordinator: Chau Le, PhD
- Email: lhmchau@dhktyduocdn.edu.vn
- Phone: +84905983797
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.