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. 2020 Dec 25;2020(12):CD004454. doi: 10.1002/14651858.CD004454.pub4

NCT01206946 2010.

Study name Effect of antenatal steroids for women at risk of late preterm delivery on neonatal respiratory morbidity
Methods Randomised parallel assignment
Setting: various hospitals in Lebanon
Blinding: participants, care provider, outcome assessor and investigator
Participants Estimated recruitment: 700 participants
Inclusion criteria: women between 34 0/7‐ 36 6/7 weeks of gestation, at high risk of preterm birth
Exclusion criteria
  • Multiple births

  • Fetal congenital malformations

  • A course of steroids within 2 weeks of randomisation

  • Multiple courses of steroids

  • Chorioamnionitis

  • Non reassuring fetal heart rate

  • Obstetrical indication of delivery

  • Active bleeding

  • Pregnancy related hypertensive disorders

  • Uncontrolled diabetes

Interventions Group 1: betamethasone: a single course of betamethasone (two doses of 12 mg/dose given at 24‐hourly intervals)
Group 2: saline: two doses of 2 mL of normal saline given at 24‐hourly intervals
Outcomes Primary outcome
Respiratory Distress Syndrome during 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. Necrotising 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)

Starting date Study start date: September 2010
Estimated completion date: September 2013
Last update was June 2011 (Status: recruiting)
Contact information Principal Investigator: Khalid Yunis, MD
American University of Beirut Medical Center
Notes