Comparison · NCT00201643-bc5f103f
Rescue Course of Betamethasone or Dexamethasone vs Placebo (Normal Saline): Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Rescue Course of Betamethasone or Dexamethasone vs Placebo (Normal Saline): Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth. Trial comparisons, record NCT00201643-bc5f103f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00201643-bc5f103f
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.436 | 0.362 | 0.512 | wilson | |
| Risk in group 2 | 0.636 | 0.561 | 0.706 | wilson | |
| Risk difference, group 1 minus group 2 | -0.201 | -0.302 | -0.093 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.684 | 0.555 | 0.844 | log | |
| Odds ratio, group 1 over group 2 | 0.441 | 0.283 | 0.687 | log | |
| Number needed to treat, for one fewer participant with the outcome on Rescue Course of Betamethasone or Dexamethasone than on Placebo (Normal Saline) | 4.98 | 3.31 | 10.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rescue Course of Betamethasone or Dexamethasone | Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart. | 71 | 163 | OG000 |
| Group 2 | Placebo (Normal Saline) | Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart. | 105 | 165 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth.
- Description
This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at \< 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death
- Time frame
- From birth to 28 days of life
- Population
This was an intent to treat protocol. In patients delivering before 34 weeks we estimated that the sample size of at least 217 subjects in each arm would be needed to have 80% power to detect a 40% reduction in neonatal morbidity (to 16.8%).
Source ClinicalTrials.gov
Trial
- Title
- A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
- NCT number
- NCT00201643
- Phases
- PHASE4
- Conditions
- Preterm Delivery
- Interventions
- Betamethasone or Dexamethasone (2nd course of ACS), Placebo
- Lead sponsor
- Obstetrix Medical Group
- Results first posted
- 2011-03-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00201643?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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