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Status unknownNCT01206946Updated Jun 23, 2011

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

A Phase 2 interventional study of Betamethasone and Normal Saline in Respiratory Distress Syndrome, Newborn and Transient Tachypnea of the Newborn, sponsored by American University of Beirut Medical Center. Status unknown at 5 sites in Lebanon. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2011-06-23.

Sponsored by American University of Beirut Medical Center · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
700
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Respiratory Distress Syndrome, Newborn
  • Transient Tachypnea of the Newborn

Keywords

  • Respiratory distress
  • Antenatal steroids
  • late preterm
03

In context

Respiratory Distress Syndrome

1,596 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 700 is above the median of 60 across 960 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

American University of Beirut Medical Center is the lead sponsor of 152 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women between 34 0/7- 36 6/7 weeks of gestation
  • High risk of preterm birth

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
700 participants (estimated)

Study arms

  • Experimental
    Antenatal steroids

    Drug: Betamethasone

  • Placebo comparator
    Normal saline

    Other: Normal Saline

Interventions

  • DrugBetamethasone

    A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals)

  • OtherNormal Saline

    Two doses of 2ml of normal saline given at 24 hourly intervals

06

What researchers measure

Primary outcomes

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

    Time frame: First three days of life

Secondary outcomes

  1. Admission to NICU

    Time frame: First three days of life

  2. Hospital stay

    Time frame: Neonatal period (28 days of life)

  3. Days on oxygen

    Time frame: Neonatal period (28 days of life)

  4. Intubations

    Time frame: First three days of life

  5. Surfactant treatment

    Time frame: First three days of life

  6. Pneumothorax

    Time frame: First three days of life

  7. Persistent Pulmonary Hypertension of the Newborn(PPHN)

    Time frame: First three days of life

  8. Days on ventilation

    Time frame: Neonatal period (28 days of life)

  9. Necrotizing enterocolitis (NEC)

    Time frame: Neonatal period (28 days of life)

  10. Clinical sepsis

    Time frame: Neonatal period (28 days of life)

  11. Intraventricular Hemorrhage (IVH)

    Time frame: First week after birth

07

Study locations

3 of 5 sites recruiting
  • American University of Beirut Medical Center
    Beirut, Lebanon
    • Khalid Yunis, MD · Principal investigator
    • Lama Charafeddine, MD · Sub investigator
    • Ziyad Mahfoud, PhD · Sub investigator
    • Anwar Nassar, MD · Sub investigator
    Recruiting
  • Bahman Hospital
    Beirut, Lebanon
    • Ali Zaytoun, MD · Principal investigator
    • Iman Charara, MD · Sub investigator
    Recruiting
  • Hotel Dieu de France
    Beirut, Lebanon
    • Imad Melki, MD · Principal investigator
    • Elie Atiyeh, MD · Sub investigator
    Not yet recruiting
  • Rafik Hariri University Hospital
    Beirut, Lebanon
    • Hassan Fakhoury, MD · Principal investigator
    • Zoulfikar Hachach, MD · Sub investigator
    Recruiting
  • St Georges Hospital- University Medical Center
    Beirut, Lebanon
    • Georged El Kehdy, MD · Principal investigator
    • Dany Hamod, MD · Sub investigator
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01206946
Lead sponsor
American University of Beirut Medical Center
First posted
Sep 22, 2010
Start date
Sep 2010
Primary completion
Sep 2013 (estimated)
Completion
Sep 2013 (estimated)
Last update
Jun 23, 2011

Study contacts

Khalid Yunis, MD
Contact
kayunis@aub.edu.lb
961-1-350000 ext. 5538
Khalid Yunis, MD
principal investigator · American University of Beirut Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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