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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01206946

Enrollment

700

Registered

2010-09-22

Start date

2010-09-30

Completion date

2013-09-30

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Newborn, Transient Tachypnea of the Newborn

Keywords

Respiratory distress, Antenatal steroids, late preterm

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.

Interventions

DRUGBetamethasone

A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals)

OTHERNormal Saline

Two doses of 2ml of normal saline given at 24 hourly intervals

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Surfactant treatment	First three days of life
Persistent Pulmonary Hypertension of the Newborn(PPHN)	First three days of life
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
Pneumothorax	First three days of life

Countries

Lebanon

Contacts

Primary ContactKhalid Yunis, MD

kayunis@aub.edu.lb961-1-350000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026