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

June 22, 2011 updated by: American University of Beirut Medical Center

Effect of Antenatal Steroids for Women at Risk of Late Preterm Delivery on Neonatal Respiratory Morbidity

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Recruiting
        • American University of Beirut Medical Center
        • Principal Investigator:
          • Khalid Yunis, MD
        • Sub-Investigator:
          • Lama Charafeddine, MD
        • Sub-Investigator:
          • Ziyad Mahfoud, PhD
        • Sub-Investigator:
          • Anwar Nassar, MD
      • Beirut, Lebanon
        • Recruiting
        • Bahman Hospital
        • Principal Investigator:
          • Ali Zaytoun, MD
        • Sub-Investigator:
          • Iman Charara, MD
      • Beirut, Lebanon
        • Not yet recruiting
        • Hotel Dieu de France
        • Principal Investigator:
          • Imad Melki, MD
        • Sub-Investigator:
          • Elie Atiyeh, MD
      • Beirut, Lebanon
        • Recruiting
        • Rafik Hariri University Hospital
        • Principal Investigator:
          • Hassan Fakhoury, MD
        • Sub-Investigator:
          • Zoulfikar Hachach, MD
      • Beirut, Lebanon
        • Not yet recruiting
        • St Georges Hospital- University Medical Center
        • Principal Investigator:
          • Georged El Kehdy, MD
        • Sub-Investigator:
          • Dany Hamod, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal saline
Other: Normal Saline
Two doses of 2ml of normal saline given at 24 hourly intervals
Experimental: Antenatal steroids
Drug: Betamethasone
A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Investigators

  • Principal Investigator: Khalid Yunis, MD, American University of Beirut Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

September 21, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED.KY.11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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