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| Name | Class |
|---|---|
| American Lung Association | OTHER |
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One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.
The primary purpose of this randomized, blinded placebo controlled trial is to quantify and compare measurements of pulmonary function (including respiratory compliance and lung volumes/functional residual capacity) of hospitalized preterm infants whose mothers received an initial course of antenatal corticosteroids, remained undelivered after 14 days and at < 34 weeks of gestation, and were then randomized to either a rescue course of antenatal corticosteroids or to a rescue course of placebo. In addition, follow-up pulmonary function tests, clinical outcomes, growth parameters, and the neurodevelopmental outcome of these infants will be followed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Betamethasone (Celestone) 12 mg intramuscular q 24 hours x 2 doses |
|
| B | Placebo Comparator | Placebo dose intramuscular q 24 hours x 2 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| betamethasone | Drug | 12 mg IM q 24 hours x 2 doses |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of Functional Residual Capacity in Preterm Infants. | Within first 72 hours after birth | |
| Measurements of Respiratory Compliance (Crs) in Preterm Infants. | Within first 72 hours after birth |
| Measure | Description | Time Frame |
|---|---|---|
| FiO2 | During initial hospital stay and planned follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia McEvoy, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20227053 | Result | McEvoy C, Schilling D, Peters D, Tillotson C, Spitale P, Wallen L, Segel S, Bowling S, Gravett M, Durand M. Respiratory compliance in preterm infants after a single rescue course of antenatal steroids: a randomized controlled trial. Am J Obstet Gynecol. 2010 Jun;202(6):544.e1-9. doi: 10.1016/j.ajog.2010.01.038. Epub 2010 Mar 15. | |
| 28436580 |
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Women who showed no further signs of preterm delivery after consent were not randomized.
This randomized trial was conducted at Oregon Health and Science University in Portland, OR and at Sacred Heart Hospital in Pensacola, FL. Subjects were recruited from June 2001 to May 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | A (Betamethasone) | Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses |
| FG001 | B (Placebo) | Placebo dose IM q 24 hours x 2 doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A (Betamethasone) | Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses betamethasone: 12 mg IM q 24 hours x 2 doses |
| BG001 | B (Placebo) | Placebo dose IM q 24 hours x 2 doses placebo: Placebo IM q 24 hours x 2 doses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measurements of Functional Residual Capacity in Preterm Infants. | Number of participants listed here is greater than the number listed in Participant flow as twin deliveries were not excluded. | Posted | Mean | Standard Deviation | mL/kg | Within first 72 hours after birth |
|
|
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Number of participants listed here is greater than the number listed in participant flow as this section includes offspring and twins were included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A (Betamethasone) | Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses | 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cindy McEvoy, MD | OHSU | 503-494-0223 | mcevoyc@ohsu.edu |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| placebo | Drug | Placebo IM q 24 hours x 2 doses |
|
| McEvoy C, Schilling D, Spitale P, O'Malley J, Bowling S, Durand M. Pulmonary function and outcomes in infants randomized to a rescue course of antenatal steroids. Pediatr Pulmonol. 2017 Sep;52(9):1171-1178. doi: 10.1002/ppul.23711. Epub 2017 Apr 24. |
| 29795314 | Result | Jordan BK, Schilling D, McEvoy CT. The window of improved neonatal respiratory compliance after rescue antenatal steroids. J Perinatol. 2018 Jul;38(7):828-833. doi: 10.1038/s41372-018-0124-9. Epub 2018 May 24. |
| 27832835 | Result | Jordan BK, Schilling D, McEvoy CT. Pulmonary Function at Hospital Discharge in Preterm Infants Randomized to a Single Rescue Course of Antenatal Steroids. J Pediatr. 2017 Feb;181:62-66.e1. doi: 10.1016/j.jpeds.2016.10.022. Epub 2016 Nov 7. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Measurements of Respiratory Compliance (Crs) in Preterm Infants. | Number of participants listed here is greater than the number listed in Participant flow as twin deliveries were not excluded. | Posted | Mean | Standard Deviation | mL/cm H2O/kg | Within first 72 hours after birth |
|
|
|
| Secondary | FiO2 | Number of participants is greater here as it includes all offspring, including twins. | Posted | Count of Participants | Participants | During initial hospital stay and planned follow-up |
|
|
|
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | B (Placebo) | Placebo dose IM q 24 hours x 2 doses | 0 | 56 | 0 | 56 | 0 | 56 |
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| D000091642 | Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |