Trial · NCT01222247
Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
NCT01222247, Phase 3, Completed, The George Washington University Biostatistics Center; results first posted 2019-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial. Trials, record NCT01222247. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01222247
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
- NCT number
- NCT01222247
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,831 participants, actual
- Lead sponsor
- The George Washington University Biostatistics Center
- Conditions
- Pregnancy, Respiratory Distress Syndrome, Pregnancy Outcomes, Preterm Birth
- Interventions
- Betamethasone, Placebo
- First posted
- 2010-10-18
- Last updated
- 2023-03-28
- Results first posted
- 2019-01-30
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neonatal Composite Outcome | 72 hours of life | Need for respiratory support: Continuous positive airway pressure (CPAP) or humidified high-flow nasal cannula (HHFNC) for greater than or equal to 2 hours or more in the first 72 hours, or fraction of inspired oxygen (FiO2) greater than or equal to 0.30 for 4 hours or more in the first 72 hours, or mechanical ventilation in the first 72 hours, or Extracorporeal membrane oxygenation (ECMO) Stillbirth, or neonatal death less than 72 hours of age |
| Secondary | Number of Neonates With Severe Respiratory Complication, | 72 hours of life | A severe respiratory complication was defined as any of the following occurrences within 72 hours after birth: CPAP or high-flow nasal cannula for at least 12 hours, supplemental oxygen with a fraction of inspired oxygen of 0.30 or more for at least 24 hours, mechanical ventilation, stillbirth or neonatal death, or the need for ECMO. Except for the duration of CPAP or high-flow nasal cannula and the duration of a fraction of inspired oxygen of 0.30 or more, the criteria for a severe respiratory complication overlap with those of the primary outcome. |
| Secondary | Neonates Needing Immediate Resuscitation After Birth | Within the first 30 minutes of birth | Need for resuscitation after birth: any intervention in the first 30 minutes other than blow-by oxygen |
| Secondary | Number of Neonates With Respiratory Distress Syndrome | Delivery | Respiratory distress defined as the presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis) with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates |
| Secondary | Number of Neonates With Transient Tachypnea of the Newborn | by 72 hours after delivery | TTN is defined as signs of respiratory distress, specifically tachypnea, that are resolved by 72 hours of age. TTN may be diagnosed in the absence of a chest X-ray or with a chest X-ray that is normal or shows signs of increased perihilar interstitial markings |
| Secondary | Number of Infants With Neonatal Apnea | 72 hours of life | Neonatal apnea with respiratory pauses of more than 20 seconds duration resulting in bradycardia or oxygen desaturation below baseline. |
| Secondary | Number of Infants withChronic Lung Disease / Bronchopulmonary Dysplasia (BPD) Requiring Supplemental Oxygen | 28 days of life | Infants requiring supplemental oxygen of more than 0.21 for the first 28 days of life |
| Secondary | Neonates With Pneumonia | by 72 hours of life | Neonatal pneumonia |
| Secondary | Number of Neonates Needing Surfactant Administration | Delivery | Administration of surfactant for neonatal respiratory treatment |
| Secondary | Neonatal Outcome Composite | 72 hours of life | Transient tachypnea of the newborn (TTN), respiratory distress syndrome (RDS), and apnea |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Neonatal Composite Outcome | 72 hours of life | The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Neonates With Severe Respiratory Complication, | 72 hours of life | The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Neonates Needing Immediate Resuscitation After Birth | Within the first 30 minutes of birth | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Neonates With Respiratory Distress Syndrome | Delivery | The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Neonates With Transient Tachypnea of the Newborn | by 72 hours after delivery | The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infants With Neonatal Apnea | 72 hours of life | The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infants withChronic Lung Disease / Bronchopulmonary Dysplasia (BPD) Requiring Supplemental Oxygen | 28 days of life | The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Neonates With Pneumonia | by 72 hours of life | The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Neonates Needing Surfactant Administration | Delivery | The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Neonatal Outcome Composite | 72 hours of life | The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Neonatal Composite Outcome | Betamethasone | Primary Outcome Composite | 165 | Participants | |
| Neonatal Composite Outcome | Placebo | Primary Outcome Composite | 202 | Participants | |
| Neonatal Composite Outcome | Betamethasone | CPAP or high-flow cannula ≥2 continuous hrs | 145 | Participants | |
| Neonatal Composite Outcome | Placebo | CPAP or high-flow cannula ≥2 continuous hrs | 184 | Participants | |
| Neonatal Composite Outcome | Betamethasone | Fraction of inspired O2 of ≥0.30 for ≥4 cont hrs | 48 | Participants | |
| Neonatal Composite Outcome | Placebo | Fraction of inspired O2 of ≥0.30 for ≥4 cont hrs | 61 | Participants | |
| Neonatal Composite Outcome | Betamethasone | Mechanical ventilation | 34 | Participants | |
| Neonatal Composite Outcome | Placebo | Mechanical ventilation | 43 | Participants | |
| Neonatal Composite Outcome | Betamethasone | Extracorporeal membrane oxygenation (ECMO) | 0 | Participants | |
| Neonatal Composite Outcome | Placebo | Extracorporeal membrane oxygenation (ECMO) | 0 | Participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Betamethasone | 1,429 | |
| Overall Study | STARTED | Placebo | 1,402 | |
| Overall Study | Received 2 Doses | Betamethasone | 860 | |
| Overall Study | Received 2 Doses | Placebo | 826 | |
| Overall Study | Received 1 Dose | Betamethasone | 568 | |
| Overall Study | Received 1 Dose | Placebo | 571 | |
| Overall Study | Did Not Receive Assigned Medication | Betamethasone | 1 | |
| Overall Study | Did Not Receive Assigned Medication | Placebo | 5 | |
| Overall Study | COMPLETED | Betamethasone | 1,427 | |
| Overall Study | COMPLETED | Placebo | 1,400 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Skin reaction at injecton site | Skin and subcutaneous tissue disorders | Betamethasone | 223 | 1,428 | 223 |
| other | Skin reaction at injecton site | Skin and subcutaneous tissue disorders | Placebo | 352 | 1,397 | 352 |
| serious | Postpartum Hemorrhage | Pregnancy, puerperium and perinatal conditions | Betamethasone | 7 | 1,429 | |
| serious | Postpartum Hemorrhage | Pregnancy, puerperium and perinatal conditions | Placebo | 5 | 1,402 | |
| serious | Hypotension | Vascular disorders | Betamethasone | 0 | 1,429 | |
| serious | Hypotension | Vascular disorders | Placebo | 1 | 1,402 | |
| serious | Seizure | Pregnancy, puerperium and perinatal conditions | Betamethasone | 1 | 1,429 | |
| serious | Seizure | Pregnancy, puerperium and perinatal conditions | Placebo | 1 | 1,402 | |
| serious | Uterine rupture | Pregnancy, puerperium and perinatal conditions | Betamethasone | 0 | 1,429 | |
| serious | Uterine rupture | Pregnancy, puerperium and perinatal conditions | Placebo | 1 | 1,402 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Betamethasone | 2 | 1,429 |
| Total, all-cause mortality | Placebo | 0 | 1,402 |
| Total, other adverse events | Betamethasone | 223 | 1,428 |
| Total, other adverse events | Placebo | 352 | 1,397 |
| Total, serious adverse events | Betamethasone | 13 | 1,429 |
| Total, serious adverse events | Placebo | 12 | 1,402 |
Source ClinicalTrials.gov
Papers25
The papers the trial lists on ClinicalTrials.gov.
Grants20
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10HD036801 | Data Coord Ctr-NICHD Cooperative Multicenter Maternal Medicine Units Research Net | CLIFTON, REBECCA GERSNOVIEZ | GEORGE WASHINGTON UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2009 to 2021 | NIH RePORTER |
| U10HD021410 | Multicenter Network of Maternal Fetal Medicine Units | CARITIS, STEVE N | MAGEE-WOMEN'S RES INST AND FOUNDATION | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027869 | NICHD Materal Fetal Medicine Units Network | TITA, ALAN THEVENET N. | UNIVERSITY OF ALABAMA AT BIRMINGHAM | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027915 | NICHD Maternal Fetal Medicine Units Network | IAMS, JAY | OHIO STATE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1992 to 2015 | NIH RePORTER |
| U10HD027917 | Co-Operative Multicenter Trials in Obstetrics & Maternal Fetal Medicine | GONIK, BERNARD | WAYNE STATE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD034116 | Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units Network (U10) | CASEY, BRIAN M | UT SOUTHWESTERN MEDICAL CENTER | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1996 to 2015 | NIH RePORTER |
| U10HD034208 | Maternal Fetal Medicine Units Network | VARNER, MICHAEL W. | UNIVERSITY OF UTAH | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1996 to 2015 | NIH RePORTER |
| U10HD040485 | Maternal Fetal Medicine Network | WAPNER, RONALD | COLUMBIA UNIVERSITY HEALTH SCIENCES | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
| U10HD040500 | Brown/WIH Eunice Kennedy Shriver NICHD MFM Units Network Site | ROUSE, DWIGHT J | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
| U10HD040512 | NICHD Maternal Fetal Medicine Units Network | GROBMAN, WILLIAM ADAM | NORTHWESTERN UNIVERSITY AT CHICAGO | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
1 to 10 of 20
See all 20 grantsTrial comparisons21
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Betamethasone vs Placebo: Number of Infants With Neonatal Sepsis | Trial comparisons |
| Betamethasone vs Placebo: Neonatal Feeding Difficulty | Trial comparisons |
| Betamethasone vs Placebo: Number of Neonates With Necrotizing Enterocolitic (NEC) | Trial comparisons |
| Betamethasone vs Placebo: Number of Neonates Needing Surfactant Administration | Trial comparisons |
| Betamethasone vs Placebo: Neonatal Morbidity Composite | Trial comparisons |
| Betamethasone vs Placebo: Birth Weight Less Than 10th Percentile | Trial comparisons |
| Betamethasone vs Placebo: Number of Infants With Neonatal Apnea | Trial comparisons |
| Betamethasone vs Placebo: Number of Neonates With Hypothermia | Trial comparisons |
| Betamethasone vs Placebo: Neonates With Pneumonia | Trial comparisons |
| Betamethasone vs Placebo: Neonates Needing Immediate Resuscitation After Birth | Trial comparisons |
1 to 10 of 21
See all 21 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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