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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by American University of Beirut Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206946
First Posted: September 22, 2010
Last Update Posted: June 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
American University of Beirut Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

Secondary Outcome 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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         
Hotel Dieu de France Not yet recruiting
Beirut, Lebanon
Principal Investigator: Imad Melki, MD         
Sub-Investigator: Elie Atiyeh, MD         
Rafik Hariri University Hospital Recruiting
Beirut, Lebanon
Principal Investigator: Hassan Fakhoury, MD         
Sub-Investigator: Zoulfikar Hachach, 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

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
First Submitted: September 21, 2010
First Posted: September 22, 2010
Last Update Posted: June 23, 2011
Last Verified: September 2010

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

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Transient Tachypnea of the Newborn
Infant, Premature, Diseases
Infant, Newborn, Diseases
Respiratory Distress Syndrome, Adult
Tachypnea
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents