Betamethasone Dosing Interval - 12 or 24 Hours?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00453141

Recruitment Status : Completed

First Posted : March 28, 2007

Last Update Posted : November 10, 2009

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by:

The Cooper Health System

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Preterm Delivery	Drug: dosing of Betamethasone	Not Applicable

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 Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Betamethasone Dosing Interval - 12 or 24 Hours?
Study Start Date :	April 2006
Actual Primary Completion Date :	October 2009
Actual Study Completion Date :	October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Betamethasone

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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 ]

Secondary Outcome Measures :

Incidence of INH, NEC, BPD, Blindness [ Time Frame: until neonatal discharge ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	16 Years to 45 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453141

Locations

Layout table for location information

United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Atlanticare Regional Medical Center
Pomona, New Jersey, United States

Sponsors and Collaborators

The Cooper Health System

Investigators

Layout table for investigator information

Principal Investigator:	Meena Khandelwal, MD	The Cooper Health System

More Information

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.

Layout table for additonal information

ClinicalTrials.gov Identifier:	NCT00453141
Other Study ID Numbers:	06030
First Posted:	March 28, 2007 Key Record Dates
Last Update Posted:	November 10, 2009
Last Verified:	March 2009

Keywords provided by The Cooper Health System:


Betamethasone for preterm labor Preterm delivery Infant Respiratory Distress Syndrome

Additional relevant MeSH terms:

Layout table for MeSH terms

Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Betamethasone	Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents

To Top