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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 NICU

Hospital 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

Page last updated: August 23, 2015

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