Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants

Overview

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.

Full Title of Study: “Effect of Antenatal Steroids for Women at Risk of Late Preterm Delivery on Neonatal Respiratory Morbidity”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2013

Interventions

  • Drug: Betamethasone
    • A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals)
  • Other: Normal Saline
    • Two doses of 2ml of normal saline given at 24 hourly intervals

Arms, Groups and Cohorts

  • Experimental: Antenatal steroids
  • Placebo Comparator: Normal saline

Clinical Trial Outcome Measures

Primary Measures

  • Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN)
    • Time Frame: First three days of life

Secondary Measures

  • Admission to NICU
    • Time Frame: First three days of life
  • Hospital stay
    • Time Frame: Neonatal period (28 days of life)
  • Days on oxygen
    • Time Frame: Neonatal period (28 days of life)
  • Intubations
    • Time Frame: First three days of life
  • Surfactant treatment
    • Time Frame: First three days of life
  • Pneumothorax
    • Time Frame: First three days of life
  • Persistent Pulmonary Hypertension of the Newborn(PPHN)
    • Time Frame: First three days of life
  • Days on ventilation
    • Time Frame: Neonatal period (28 days of life)
  • Necrotizing enterocolitis (NEC)
    • Time Frame: Neonatal period (28 days of life)
  • Clinical sepsis
    • Time Frame: Neonatal period (28 days of life)
  • Intraventricular Hemorrhage (IVH)
    • Time Frame: First week after birth

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • American University of Beirut Medical Center
  • Provider of Information About this Clinical Study
    • Dr. Khalid Yunis, American University of Beirut Medical Center
  • Overall Official(s)
    • Khalid Yunis, MD, Principal Investigator, American University of Beirut Medical Center
  • Overall Contact(s)
    • Khalid Yunis, MD, 961-1-350000, kayunis@aub.edu.lb

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.