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

Primary Purpose

Respiratory Distress Syndrome, Newborn, Transient Tachypnea of the Newborn

Status
Unknown status
Phase
Phase 2
Locations
Lebanon
Study Type
Interventional
Intervention
Betamethasone
Normal Saline
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Distress Syndrome, Newborn focused on measuring Respiratory distress, Antenatal steroids, late preterm

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • American University of Beirut Medical CenterRecruiting
  • Bahman HospitalRecruiting
  • Hotel Dieu de France
  • Rafik Hariri University HospitalRecruiting
  • St Georges Hospital- University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Antenatal steroids

Normal saline

Arm Description

Outcomes

Primary Outcome Measures

Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN)

Secondary Outcome Measures

Admission to NICU
Hospital stay
Days on oxygen
Intubations
Surfactant treatment
Pneumothorax
Persistent Pulmonary Hypertension of the Newborn(PPHN)
Days on ventilation
Necrotizing enterocolitis (NEC)
Clinical sepsis
Intraventricular Hemorrhage (IVH)

Full Information

First Posted
September 21, 2010
Last Updated
June 22, 2011
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01206946
Brief Title
Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants
Official Title
Effect of Antenatal Steroids for Women at Risk of Late Preterm Delivery on Neonatal Respiratory Morbidity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn, Transient Tachypnea of the Newborn
Keywords
Respiratory distress, Antenatal steroids, late preterm

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antenatal steroids
Arm Type
Experimental
Arm Title
Normal saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Betamethasone
Intervention Description
A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals)
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
Two doses of 2ml of normal saline given at 24 hourly intervals
Primary Outcome Measure Information:
Title
Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN)
Time Frame
First three days of life
Secondary Outcome Measure Information:
Title
Admission to NICU
Time Frame
First three days of life
Title
Hospital stay
Time Frame
Neonatal period (28 days of life)
Title
Days on oxygen
Time Frame
Neonatal period (28 days of life)
Title
Intubations
Time Frame
First three days of life
Title
Surfactant treatment
Time Frame
First three days of life
Title
Pneumothorax
Time Frame
First three days of life
Title
Persistent Pulmonary Hypertension of the Newborn(PPHN)
Time Frame
First three days of life
Title
Days on ventilation
Time Frame
Neonatal period (28 days of life)
Title
Necrotizing enterocolitis (NEC)
Time Frame
Neonatal period (28 days of life)
Title
Clinical sepsis
Time Frame
Neonatal period (28 days of life)
Title
Intraventricular Hemorrhage (IVH)
Time Frame
First week after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khalid Yunis, MD
Phone
961-1-350000
Ext
5538
Email
kayunis@aub.edu.lb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid Yunis, MD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut Medical Center
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khalid Yunis, MD
First Name & Middle Initial & Last Name & Degree
Lama Charafeddine, MD
First Name & Middle Initial & Last Name & Degree
Ziyad Mahfoud, PhD
First Name & Middle Initial & Last Name & Degree
Anwar Nassar, MD
Facility Name
Bahman Hospital
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Zaytoun, MD
First Name & Middle Initial & Last Name & Degree
Iman Charara, MD
Facility Name
Hotel Dieu de France
City
Beirut
Country
Lebanon
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imad Melki, MD
First Name & Middle Initial & Last Name & Degree
Elie Atiyeh, MD
Facility Name
Rafik Hariri University Hospital
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hassan Fakhoury, MD
First Name & Middle Initial & Last Name & Degree
Zoulfikar Hachach, MD
Facility Name
St Georges Hospital- University Medical Center
City
Beirut
Country
Lebanon
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georged El Kehdy, MD
First Name & Middle Initial & Last Name & Degree
Dany Hamod, MD

12. IPD Sharing Statement

Learn more about this trial

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

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