Betamethasone Dosing Interval - 12 or 24 Hours?

• ClinicalTrials.gov Identifier: NCT00453141
• Recruitment Status: Completed
• First Posted: March 28, 2007
• Last Update Posted: November 10, 2009
• Sponsor: The Cooper Health System
• Information provided by: The Cooper Health System

Tracking Information

• First Submitted Date: March 26, 2007
• First Posted Date: March 28, 2007
• Last Update Posted Date: November 10, 2009
• Study Start Date: April 2006
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 7, 2009): The diagnosis of RDS is defined as: PaO2 < 50 mm Hg in room air, central cyanosis in room air, or a requirement for supplemental O2 to maintain PaO2 > 50 mm Hg, along with chest xray findings consistent with RDS (per the Vermont Oxford Network) [ Time Frame: Until neonatal discharge ]

Original Primary Outcome Measures (submitted: March 27, 2007)

• The diagnosis of RDS is defined as: PaO2 < 50 mm Hg in room air, central cyanosis in room air, or a requirement for supplemental O2 to maintain PaO2 > 50 mm Hg, along with chest xray findings consistent with RDS (per the Vermont Oxford Network)
• It would be useful to know if administration of betamethasone at an interval of less than 24 hours would have a positive impact on decreasing the incidence of RDS.

• Current Secondary Outcome Measures (submitted: November 7, 2009): Incidence of INH, NEC, BPD, Blindness [ Time Frame: until neonatal discharge ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Betamethasone Dosing Interval - 12 or 24 Hours?
• Official Title: Betamethasone Dosing Interval - 12 or 24 Hours?
• Brief Summary: The purpose of this study is to determine if there may be a benefit to the newborn if betamethasone is given 12 hours apart instead of 24 hours apart.
• Detailed Description: Betamethasone is a medicine given to women expected to deliver after 24 but before 34 weeks of pregnancy. It is very advantageous in preventing or decreasing the many problems these small babies may face if born early. Betamethasone makes breathing easier for them, also decreases the chance of them bleeding in the head and makes their chances of survival better. This medicine is used routinely in pregnancy but the best timing between doses in not well established. The 'standard' dosing schedule involves giving 2 injections of 12mg of the medicine 24 hours apart. However, many women deliver before reaching the 24-hour mark, despite the doctors best efforts to try and delay delivery, and therefore miss the opportunity for the 2nd dose.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Preterm Delivery
• Intervention: Drug: dosing of Betamethasone
• Study Arms: Not Provided
• Publications *: Liggins GC, Howie RN. A controlled trial of antepartum glucocorticoid treatment for prevention of the respiratory distress syndrome in premature infants. Pediatrics. 1972 Oct;50(4):515-25. No abstract available.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: March 27, 2007): 200
• Original Enrollment: Same as current
• Actual Study Completion Date: October 2009
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Pregnant women expected to deliver preterm (either induced or spontaneously) for any obstetrical or medical indication.
• Gestational age between 23 and 34 weeks gestational age.
• Dating must either be by LMP which is consistent with ultrasound performed at any gestational age, or calculated by a sonogram less than or equal to 23 weeks.

Exclusion Criteria:

• Patients at <23 or >34 weeks gestational age.
• Known drug allergy to betamethasone.
• Given steroid other than betamethasone for lung maturation.
• Any contraindication to steroid therapy.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 16 Years to 45 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00453141
• Other Study ID Numbers: 06030
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: The Cooper Health System
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Meena Khandelwal, MD; The Cooper Health System

• PRS Account: The Cooper Health System
• Verification Date: March 2009