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

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01206946
• Other study ID #: PED.KY.11
• Status: Recruiting
• Phase: Phase 2
• First received: September 21, 2010
• Last updated: June 22, 2011
• Start date: September 2010
• Est. completion date: September 2013

Study information

• Verified date: September 2010
• Source: American University of Beirut Medical Center
• Contact: Khalid Yunis, MD
• Phone: 961-1-350000
• Email: kayunis[@]aub.edu.lb
• Is FDA regulated: No
• Health authority: Lebanon: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Transient Tachypnea of the Newborn

Intervention

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

Other:
• Normal Saline
Two doses of 2ml of normal saline given at 24 hourly intervals

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut
Lebanon	Bahman Hospital	Beirut
Lebanon	Hotel Dieu de France	Beirut
Lebanon	Rafik Hariri University Hospital	Beirut
Lebanon	St Georges Hospital- University Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN)		First three days of life	No
Secondary	Admission to NICU		First three days of life	No
Secondary	Hospital stay		Neonatal period (28 days of life)	No
Secondary	Days on oxygen		Neonatal period (28 days of life)	No
Secondary	Intubations		First three days of life	No
Secondary	Surfactant treatment		First three days of life	No
Secondary	Pneumothorax		First three days of life	No
Secondary	Persistent Pulmonary Hypertension of the Newborn(PPHN)		First three days of life	No
Secondary	Days on ventilation		Neonatal period (28 days of life)	No
Secondary	Necrotizing enterocolitis (NEC)		Neonatal period (28 days of life)	No
Secondary	Clinical sepsis		Neonatal period (28 days of life)	No
Secondary	Intraventricular Hemorrhage (IVH)		First week after birth	No