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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Antenatal Steroids for Women at Risk of Late Preterm Delivery on Neonatal Respiratory Morbidity

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

Intervention / Treatment
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* Drug: Betamethasone
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antenatal steroids<br> | Drug: Betamethasone<br>* A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals)<br>|
| Placebo Comparator: Normal saline<br> | Other: Normal Saline<br>* Two doses of 2ml of normal saline given at 24 hourly intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN) |  | First three days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission to NICU |  | First three days of life | 
| Hospital stay |  | Neonatal period (28 days of life) | 
| Days on oxygen |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory distress, Antenatal steroids, late preterm