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

This study is currently recruiting participants.
Verified September 2010 by American University of Beirut Medical Center
Sponsor:
Information provided by:
American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT01206946
First received: September 21, 2010
Last updated: June 22, 2011
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Respiratory Distress Syndrome, Newborn
Transient Tachypnea of the Newborn
 Drug: Betamethasone
Other: Normal Saline
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Antenatal Steroids for Women at Risk of Late Preterm Delivery on Neonatal Respiratory Morbidity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN) [ Time Frame: First three days of life ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Admission to NICU [ Time Frame: First three days of life ] [ Designated as safety issue: No ]
  • Hospital stay [ Time Frame: Neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • Days on oxygen [ Time Frame: Neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • Intubations [ Time Frame: First three days of life ] [ Designated as safety issue: No ]
  • Surfactant treatment [ Time Frame: First three days of life ] [ Designated as safety issue: No ]
  • Pneumothorax [ Time Frame: First three days of life ] [ Designated as safety issue: No ]
  • Persistent Pulmonary Hypertension of the Newborn(PPHN) [ Time Frame: First three days of life ] [ Designated as safety issue: No ]
  • Days on ventilation [ Time Frame: Neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • Necrotizing enterocolitis (NEC) [ Time Frame: Neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • Clinical sepsis [ Time Frame: Neonatal period (28 days of life) ] [ Designated as safety issue: No ]
  • Intraventricular Hemorrhage (IVH) [ Time Frame: First week after birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antenatal steroids Drug: Betamethasone
A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals)
Placebo Comparator: Normal saline Other: Normal Saline
Two doses of 2ml of normal saline given at 24 hourly intervals

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206946

Contacts
Contact: Khalid Yunis, MD 961-1-350000 ext 5538 kayunis@aub.edu.lb

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

No publications provided

Responsible Party: Dr. Khalid Yunis, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01206946     History of Changes
Other Study ID Numbers: PED.KY.11
Study First Received: September 21, 2010
Last Updated: June 22, 2011
Health Authority: Lebanon: Ministry of Public Health

Keywords provided by American University of Beirut Medical Center:
Respiratory distress
Antenatal steroids
late preterm

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 13, 2013