Effectiveness of ACS in Extreme Preemies
|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: NCT02351310|
Recruitment Status : Withdrawn (Company decided not to pursue this study.)
First Posted : January 30, 2015
Last Update Posted : March 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Preterm Labor Premature Birth||Drug: Betamethasone Genetic: Placebo||Phase 3|
The purpose of this study to evaluate the effects of antenatal corticosteroid administration (ACS) vs. placebo in patients who are threatening to deliver prematurely with well-established gestational ages between 22 0/7 and 23 6/7 weeks at the time of admission. If the delivery can be safely delayed at least 3 hours and there is no contraindication to steroid administration, the patient is eligible to be randomized. Randomization will be blinded to the patient and the staff caring for the patient and will be stratified by gestational age: those at 22 0/7 to 22 6/7 weeks and those at 23 0/7 weeks to 23 6/7 weeks. Randomized patients will be assignment to either active drug or placebo at the doses and frequencies below:
- 2 doses of Betamethasone, 12 mg intramuscularly (IM), 24 hours apart, or if as in some hospitals occasionally occurs and betamethasone is unavailable -
- 4 doses of Dexamethasone IM 6 mg, 12 hours apart.
Remainder of care will be at the discretion of the clinician.
Randomized 22 0/7 - 22 6/7:
For patients randomized between 22 0/7 and 22 6/7 weeks and who are undelivered > 24 0/7 weeks, the decision as to whether to administer an additional course or courses of ACS will also be at the discretion of the clinician.
Randomized 23 0/7 to 23 6/7:
For those patients randomized at 23 0/7 to 23 6/7 weeks and who remain undelivered > 24 0/7 weeks and < 1 week after study medication was administered, a second blinded set of medications/placebos will be provided. For patients who received Betamethasone (or dexamethasone) placebo will be provided and for those who received placebo Betamethasone will be provided.(for both at the doses described in 3.4.3). In this group, at any time > 24 0/7 weeks and less than one week of the previous dose, if the clinician feels the patient is still at risk for delivering, this second blinded set of study drugs will be administered. This will allow the patient to receive at least one actual course of ACS if undelivered at 24w0d. In this group, if the patient remains undelivered at > 25 weeks, administration of an open label course of ACS will be at the discretion of the MD.
Primary Outcome of this study is composite morbidity and mortality. The N on this study is 68 (34 in each group)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effects of Antenatal Corticosteroids in Patients With Early (22 - 23w6d) Threatened Preterm Birth|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Active Comparator: Betamethasone
Betamethasone: 12 mg given intramuscularly (IM), 24 hours apart or if as in some hospitals occasionally occurs and betamethasone is unavailable - • 4 doses of Dexamethasone IM 6 mg, 12 hours apart
Course of ACS given intramuscularly (2 doses of 12 mg, 24 hours apart)
Other Name: ACS
Placebo Comparator: Normal Saline
Quantity Sufficient (QS) of Normal Saline (NS) given intramuscularly (IM), 24 hours apart or if hospital is using Dexamethasone in place of Betamethasone then administer NS x 4 doses 12 hours apart
Course of placebo drug given intramuscularly (2 doses of normal saline (of equal quantity) 24 hours apart).
Other Name: Normal Saline
- Composite Neonatal Morbidity [ Time Frame: First 30 days after birth ]Defined as one or more of the following: fetal death, neonatal death within 30 days of delivery, respiratory distress syndrome (oxygen requirement, clinical diagnosis and consistent chest x-ray), bronchopulmonary dysplasia (requirement for oxygen support at 30 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia, blood culture proven sepsis, necrotizing enterocolitis (NEC).
- Preterm Birth prior to 34weeks gestational age. [ Time Frame: From entry into the study until 34 weeks gestational age. ]Preterm birth that occurs between the time of enrollment into the study (22w0d-23w6d) until 34w6d.
- Respiratory Distress Syndrome (RDS) [ Time Frame: First 30 days after birth ]RDS is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or ￼ with respiratory insufficiency of prematurity requiring ventilator support are present.
- Birth Weight [ Time Frame: Measured at time of birth ]newborns birth weight
- Newborn Head Circumference measurement [ Time Frame: Measured at time of birth ]Measurement of newborn head circumference done at time of birth.
- Need for Newborn Surfactant Therapy [ Time Frame: First 30 days after birth ]administration of newborn surfactant therapy within the first 30day of life.
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): NCT02351310
|Study Director:||Thomas J Garite, MD||Mednax Center for Research, Education, Quality and Safety|