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

Phase 2

• Conditions: Respiratory Distress Syndrome, Newborn; Transient Tachypnea of the Newborn
• Interventions: Drug: Betamethasone; Other: Normal Saline

• Registration Number: NCT01206946
• Lead Sponsor: American University of Beirut Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Study First Submitted: 2010-09-21
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antenatal steroids	Betamethasone	-
Normal saline	Normal Saline	-

Primary Outcome Measures

Name	Time	Method
Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN)	First three days of life

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon

Bahman Hospital; 🇱🇧 Beirut, Lebanon

Rafik Hariri University Hospital; 🇱🇧 Beirut, Lebanon

St Georges Hospital- University Medical Center; 🇱🇧 Beirut, Lebanon

Hotel Dieu de France; 🇱🇧 Beirut, Lebanon