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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antenatal steroids | Experimental |
| |
| Normal saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethasone | Drug | A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN) | First three days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Admission to NICU | First three days of life | |
| Hospital stay | Neonatal period (28 days of life) | |
| Days on oxygen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khalid Yunis, MD | Contact | 961-1-350000 | 5538 | kayunis@aub.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Khalid Yunis, MD | American University of Beirut Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut Medical Center | Recruiting | Beirut | Lebanon |
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| Normal Saline | Other | Two doses of 2ml of normal saline given at 24 hourly intervals |
|
| Neonatal period (28 days of life) |
| Intubations | First three days of life |
| Surfactant treatment | First three days of life |
| Pneumothorax | First three days of life |
| Persistent Pulmonary Hypertension of the Newborn(PPHN) | First three days of life |
| Days on ventilation | Neonatal period (28 days of life) |
| Necrotizing enterocolitis (NEC) | Neonatal period (28 days of life) |
| Clinical sepsis | Neonatal period (28 days of life) |
| Intraventricular Hemorrhage (IVH) | First week after birth |
| Bahman Hospital | Recruiting | Beirut | Lebanon |
|
| Hotel Dieu de France | Not yet recruiting | Beirut | Lebanon |
|
| Rafik Hariri University Hospital | Recruiting | Beirut | Lebanon |
|
| St Georges Hospital- University Medical Center | Not yet recruiting | Beirut | Lebanon |
|
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D059245 | Transient Tachypnea of the Newborn |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D059246 | Tachypnea |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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