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

American University of Beirut Medical Center5 sites in 1 country700 target enrollmentSeptember 2010

ConditionsRespiratory Distress Syndrome, Newborn Transient Tachypnea of the Newborn

InterventionsBetamethasone Normal Saline

DrugsBetamethasone

Overview

Phase: Phase 2
Intervention: Betamethasone
Conditions: Respiratory Distress Syndrome, Newborn
Sponsor: American University of Beirut Medical Center
Enrollment: 700
Locations: 5
Primary Endpoint: Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN)
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

September 2013

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

American University of Beirut Medical Center

Eligibility Criteria

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

Arms & Interventions

Antenatal steroids

Intervention: Betamethasone

Normal saline

Intervention: Normal Saline

Outcomes

Primary Outcomes

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

Time Frame: First three days of life

Secondary Outcomes

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)