Low dose corticosteroids to prevent respiratory issues in late preterm infants

Low Dose Antenatal Corticosteroids for Late Preterm Delivery (LoDAC Study)

This study tests if a lower dose of a steroid given to pregnant women at risk of early delivery can help prevent breathing problems in their late preterm babies.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1510 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Rambam Health Care Campus (Academic / other)
• Locations: 16 sites (Afula and 15 other locations)
• Trial ID: NCT05698966 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a reduced dose of antenatal betamethasone in preventing respiratory problems in late preterm infants born between 34 and 36 weeks of gestation. Women at high risk for late preterm delivery will be randomly assigned to receive either a full dose or a quarter dose of betamethasone, administered 24 hours apart. The main outcome measure will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in both groups, aiming to determine if the lower dose is non-inferior to the standard dose.

Who should consider this trial

Good fit: Ideal candidates are pregnant women with singleton pregnancies at 34 to 36 weeks of gestation who are at high risk for late preterm delivery.

Not a fit: Patients who have already received a full course of betamethasone or are expected to deliver in less than 12 hours will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the incidence of respiratory complications in late preterm infants while minimizing medication exposure.

How similar studies have performed: Previous studies have shown mixed results regarding the use of antenatal corticosteroids in late preterm pregnancies, indicating that while some approaches have been effective, this specific reduced dose strategy is relatively novel.

Eligibility criteria

Inclusion Criteria:- - Singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation at risk for / high probability of delivery in the late preterm period (34+0-36+5 weeks of gestation).

Criteria for determination of late preterm delivery risk:

1. Preterm uterine contractions with intact membranes, and at least 3 cm dilation or 75% cervical effacement
2. Spontaneous rupture of the membranes
3. Expected preterm delivery for any other indication via induction or cesarean between 24 hours to 7 days after the planned randomization, as determined by the obstetric provider.

   \-

   Exclusion Criteria: They had already received a full course of betamethasone.
   * Expected delivery in less than 12 hours, irrespective of cause including: 1)ruptured membranes in the presence of more than 6 contractions per hour or cervical dilation of 3 centimeters or more unless oxytocin was withheld for at least 12 hours (although other induction agents were allowed), 2) chorioamnionitis, 3) cervical dilation of 8 cm or more, and 4) evidence of non-reassuring fetal status requiring immediate delivery.
   * Prior ACS treatment
   * Current known or suspected infection ( viral, bacterial or other)
   * Pre-gestational diabetes mellitus.
   * Any infection that required antibiotics or hospitalization in the month prior to study allocation - Poor understanding of the inform consent language

Where this trial is running

Afula and 15 other locations

• Emek Medical Center — Afula, Israel (Recruiting)
• Kaplan Medical Center — Ashkelon, Israel (Recruiting)
• Soroka Medical Center — Beersheba, Israel (Recruiting)
• Hilel Yafee Medical Center — Hadera, Israel (Recruiting)
• Bnai Zion Medical Center — Haifa, Israel (Recruiting)
• Carmel Medical Center — Haifa, Israel (Recruiting)
• Rambam Health Care Cmpus — Haifa, Israel (Recruiting)
• Hadassah Ein Karem — Jerusalem, Israel (Recruiting)
• Hadassah Har Hzofim — Jerusalem, Israel (Recruiting)
• Shaare Zedek Medical Center — Jerusalem, Israel (Recruiting)
• Meir medical center — Kfar Saba, Israel (Recruiting)
• Galilee Medical Center — Nahariya, Israel (Recruiting)
• Rabin Medical Center — Petah Tikva, Israel (Recruiting)
• Sheba Medical Center — Ramat Gan, Israel (Recruiting)
• Ziv Medical Center — Safed, Israel (Recruiting)
• Sourasky Medical Center — Tel Aviv, Israel (Recruiting)

Study contacts

• Study coordinator: Ron Beloosesky, MD

Conditions Respiratory Morbidity; Preterm Labor; corticosteroids; low dose; late prerterm