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

American University of Beirut Medical Center

Status and phase: Unknown; Phase 2

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

Treatments: Other: Normal Saline; Drug: Betamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01206946

PED.KY.11

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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700 participants in 2 patient groups, including a placebo group

Antenatal steroids

Experimental group

Treatment:

Drug: Betamethasone

Normal saline

Placebo Comparator group

Treatment:

Other: Normal Saline