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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:
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
  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:


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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206946

Locations
Lebanon
American University of Beirut Medical Center
Beirut, Lebanon
Bahman Hospital
Beirut, Lebanon
Hotel Dieu de France
Beirut, Lebanon
Rafik Hariri University Hospital
Beirut, Lebanon
St Georges Hospital- University Medical Center
Beirut, Lebanon
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 
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
Tachypnea
Transient Tachypnea of the Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
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

ClinicalTrials.gov processed this record on December 09, 2016