Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants
Information source: American University of Beirut Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Respiratory Distress Syndrome, Newborn; Transient Tachypnea of the Newborn
Intervention: Betamethasone (Drug); Normal Saline (Other)
Phase: Phase 2
Status: Recruiting
Sponsored by: American University of Beirut Medical Center Official(s) and/or principal investigator(s): Khalid Yunis, MD, Principal Investigator, Affiliation: American University of Beirut Medical Center
Overall contact: Khalid Yunis, MD, Phone: 961-1-350000, Ext: 5538, Email: kayunis@aub.edu.lb
Summary
The hypothesis of the study is that administration of antenatal steroid to women at high
risk of preterm birth after 34 weeks of gestation would reduce the risk of respiratory
complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of
the Newborn (TTN) in late preterm babies.
Clinical Details
Official title: Effect of Antenatal Steroids for Women at Risk of Late Preterm Delivery on Neonatal Respiratory Morbidity
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN)
Secondary outcome: Admission to NICUHospital stay Days on oxygen Intubations Surfactant treatment Pneumothorax Persistent Pulmonary Hypertension of the Newborn(PPHN) Days on ventilation Necrotizing enterocolitis (NEC) Clinical sepsis Intraventricular Hemorrhage (IVH)
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Women between 34 0/7- 36 6/7 weeks of gestation
- High risk of preterm birth
Exclusion Criteria:
- Multiple births
- Fetal congenital malformations
- A course of steroids within 2 weeks of randomization
- Multiple courses of steroids
- Chorioamnionitis
- Non reassuring fetal heart rate
- Obstetrical indication of delivery
- Active bleeding
- Pregnancy related hypertensive disorders
- Uncontrolled diabetes
Locations and Contacts
Khalid Yunis, MD, Phone: 961-1-350000, Ext: 5538, Email: kayunis@aub.edu.lb
American University of Beirut Medical Center, Beirut, Lebanon; Recruiting Khalid Yunis, MD, Principal Investigator Lama Charafeddine, MD, Sub-Investigator Ziyad Mahfoud, PhD, Sub-Investigator Anwar Nassar, MD, Sub-Investigator
Bahman Hospital, Beirut, Lebanon; Recruiting Ali Zaytoun, MD, Principal Investigator Iman Charara, MD, Sub-Investigator
Hotel Dieu de France, Beirut, Lebanon; Not yet recruiting Imad Melki, MD, Principal Investigator Elie Atiyeh, MD, Sub-Investigator
Rafik Hariri University Hospital, Beirut, Lebanon; Recruiting Hassan Fakhoury, MD, Principal Investigator Zoulfikar Hachach, MD, Sub-Investigator
St Georges Hospital- University Medical Center, Beirut, Lebanon; Not yet recruiting Georged El Kehdy, MD, Principal Investigator Dany Hamod, MD, Sub-Investigator
Additional Information
Starting date: September 2010
Last updated: June 22, 2011
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