Trial · NCT01353313
Hydrocortisone for BPD
NCT01353313, Phase 3, Completed, NICHD Neonatal Research Network; results first posted 2022-08-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Hydrocortisone for BPD. Trials, record NCT01353313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01353313
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hydrocortisone for BPD
- NCT number
- NCT01353313
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 800 participants, actual
- Lead sponsor
- NICHD Neonatal Research Network
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature, Bronchopulmonary Dysplasia
- Interventions
- Hydrocortisone, Placebo
- First posted
- 2011-05-13
- Last updated
- 2025-02-27
- Results first posted
- 2022-08-19
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) | From day of randomization to 36 weeks post menstrual age | Survival without moderate or severe physiologic BPD at 36 weeks postmenstrual age. Moderate or severe physiologic BPD is defined as a requirement for supplemental oxygen and/or positive airway pressure to maintain oxygen saturation greater than 90 percent. A room air challenge was performed for infants estimated to be receiving less than 0.30 FiO2 by nasal cannula. |
| Primary | Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) | From day of randomization to 22-26 months corrected age | Survival without moderate or severe neurodevelopmental impairment (NDI) at 22-26 months corrected age. NDI is defined as defined as any of: Bayley Scales of Infant and Toddler Development-III (Bayley-III) cognitive composite score less than 85 (standardized mean 100, SD 15, range 55-145) or motor composite score less than 85 (standardized mean 100, range 45-155) (lower scores indicating greater impairment), Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment), severe vision impairment in both eyes (consistent with refraction from less than 20 to 200), or bilateral hearing impairment with or without amplification (by report). |
| Secondary | Number of Participants With Successful Extubation | From day of randomization to day 14 post randomization | Successful extubation during the intervention period, defined as remaining extubated for greater than or equal to 1 week, including greater than or equal to 3 days after the last dose of study medication. An extubation attempt was required after 72 hours of study drug and 24 hours after meeting the following: FiO2 less than 0.40 to maintain a saturation of greater than or equal to 88 percent, mean airway pressure less than 8 cm H2O, and hemodynamically stable in the opinion of the clinical team. |
| Secondary | Total Deaths Before Discharge | From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | Infant died before discharge home. |
| Secondary | Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual Age | At 36 weeks postmenstrual age | BPD grade at 36 weeks postmenstrual age. BPD grades are defined as: 1. No support/room air; 2. Nasal cannula (NC) O2 less than or equal to 2L; 3. NC O2 greater than 2L or CPAP/NIPPV; 4. Invasive PPV |
| Secondary | Days of Mechanical Ventilation to 36 Weeks Postmenstrual Age (PMA) | From birth to 36 weeks postmenstrual age | Number of days on mechanical ventilation (using high frequency ventilator or conventional ventilator) |
| Secondary | Duration of Oxygen Supplementation up to Status | From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | Number of days of oxygen supplementation from birth to discharge home |
| Secondary | Length of Hospital Stay in Days Among Survivors to Discharge | From birth up to one year | Number of days infant stayed in hospitals, among those who survived to discharge |
| Secondary | Number of Participants With Dexamethasone Given Before 36 Weeks Postmenstrual Age (PMA) | From birth to 36 weeks postmenstrual age | Infant received dexamethasone anytime before 36 weeks postmenstrual age. |
| Secondary | Number of Participants With Normal/Mild, Moderate or Severe/Profound NDI | At 22-26 months corrected age | Severity of neurodevelopmental impairment, defined as one or more of: Bayley Scales of Infant Development-III (Bayley-III) cognitive score \<85 (standardized mean 100, SD 15, range 55-145), Bayley-III motor score \<85 (standardized mean 100, range 45-155), Gross Motor Function Classification System (GMFCS) level ≥2, severe vision impairment in both eyes (consistent with refraction \<20-200), or bilateral hearing impairment with or without amplification (by report). Bayley-III = Bayley Scales of Infant Development III (Cognitive score standardized mean 100, SD 15, range 55-145 motor score standardized mean 100, range 45-155; higher score indicates better performance (20)) |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) | From day of randomization to 36 weeks post menstrual age | The analysis population includes all randomized infants with available data at hospital discharge. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) | From day of randomization to 22-26 months corrected age | The analysis population includes all randomized infants with available data at the two-year followup. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Successful Extubation | From day of randomization to day 14 post randomization | The analysis population includes all randomized infants with available data at hospital discharge. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total Deaths Before Discharge | From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | The analysis population includes all randomized infants with available data at hospital discharge. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual Age | At 36 weeks postmenstrual age | The analysis population includes all randomized infants with available data at hospital discharge. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Days of Mechanical Ventilation to 36 Weeks Postmenstrual Age (PMA) | From birth to 36 weeks postmenstrual age | The analysis population includes all randomized infants with available data at hospital discharge. | Days | MEDIAN |
| SECONDARY | Duration of Oxygen Supplementation up to Status | From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | The analysis population includes all randomized infants with available data who survived up to hospital discharge. | Days | MEDIAN |
| SECONDARY | Length of Hospital Stay in Days Among Survivors to Discharge | From birth up to one year | The analysis population includes all randomized infants with available data at hospital discharge. | Days | MEDIAN |
| SECONDARY | Number of Participants With Dexamethasone Given Before 36 Weeks Postmenstrual Age (PMA) | From birth to 36 weeks postmenstrual age | The analysis population includes all randomized infants with available data at hospital discharge. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Normal/Mild, Moderate or Severe/Profound NDI | At 22-26 months corrected age | The analysis population includes all randomized infants with available data who survived up to the two-year followup. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group142
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) | Hydrocortisone | Moderate/severe BPD or death | 332 | Participants | |
| Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) | Placebo | Moderate/severe BPD or death | 349 | Participants | |
| Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) | Hydrocortisone | Survival without moderate/severe physiologic bronchopulmonary dysplasia (BPD) | 66 | Participants | |
| Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) | Placebo | Survival without moderate/severe physiologic bronchopulmonary dysplasia (BPD) | 53 | Participants | |
| Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) | Hydrocortisone | Moderate/severe NDI or death | 226 | Participants | |
| Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) | Placebo | Moderate/severe NDI or death | 226 | Participants | |
| Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) | Hydrocortisone | Survival without moderate/severe neurodevelopmental impairment (NDI) | 132 | Participants | |
| Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) | Placebo | Survival without moderate/severe neurodevelopmental impairment (NDI) | 134 | Participants | |
| Number of Participants With Successful Extubation | Hydrocortisone | Successful extubation | 178 | Participants | |
| Number of Participants With Successful Extubation | Placebo | Successful extubation | 135 | Participants |
1 to 10 of 142Source ClinicalTrials.gov
See all 142 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hydrocortisone | 398 | |
| Overall Study | STARTED | Placebo | 402 | |
| Overall Study | Completed Assessment for Neurodevelopmental Impairment | Hydrocortisone | 321 | |
| Overall Study | Completed Assessment for Neurodevelopmental Impairment | Placebo | 318 | |
| Overall Study | Died After Discharge | Hydrocortisone | 8 | |
| Overall Study | Died After Discharge | Placebo | 6 | |
| Overall Study | Died Before Discharge | Hydrocortisone | 35 | |
| Overall Study | Died Before Discharge | Placebo | 40 | |
| Overall Study | Survived to Discharge | Hydrocortisone | 363 | |
| Overall Study | Survived to Discharge | Placebo | 362 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events126
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 | Thrombocytopenia | Blood and lymphatic system disorders | Hydrocortisone | 0 | 398 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 1 | 402 | |
| other | Supraventricular tachycardia | Cardiac disorders | Hydrocortisone | 0 | 398 | |
| other | Supraventricular tachycardia | Cardiac disorders | Placebo | 2 | 402 | |
| other | Tachycardia | Cardiac disorders | Hydrocortisone | 1 | 398 | |
| other | Tachycardia | Cardiac disorders | Placebo | 0 | 402 | |
| other | Adrenal insufficiency neonatal | Congenital, familial and genetic disorders | Hydrocortisone | 22 | 398 | |
| other | Adrenal insufficiency neonatal | Congenital, familial and genetic disorders | Placebo | 24 | 402 | |
| other | Patent ductus arteriosus | Congenital, familial and genetic disorders | Hydrocortisone | 1 | 398 | |
| other | Patent ductus arteriosus | Congenital, familial and genetic disorders | Placebo | 0 | 402 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydrocortisone | 43 | 398 |
| Total, all-cause mortality | Placebo | 46 | 402 |
| Total, other adverse events | Hydrocortisone | 106 | 398 |
| Total, other adverse events | Placebo | 95 | 402 |
| Total, serious adverse events | Hydrocortisone | 84 | 398 |
| Total, serious adverse events | Placebo | 95 | 402 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants21
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 |
|---|---|---|---|---|---|---|
| U24HL137729 | 2/2 Hydrocortisone for BPD Respiratory and Developmental Outcomes Study (HYBRiD Outcomes Study): Data Coordinating Center | DAS, ABHIK | RESEARCH TRIANGLE INSTITUTE | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2017 to 2023 | NIH RePORTER |
| U10HD036790 | Neonatal Research Network Data Coordinating Center (DCC) | DAS, ABHIK | RESEARCH TRIANGLE INSTITUTE | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2008 to 2017 | NIH RePORTER |
| UG3HL137872 | 1/2 Hydrocortisone for BPD Respiratory and Developmental Outcomes Study (HYBRiD Outcomes Study): Clinical Coordinating Center | DEMAURO, SARA BONAMO; HINTZ, SUSAN; KALLAPUR, SUHAS; KIRPALANI, HARESH | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2017 | NIH RePORTER |
| U10HD021364 | Multicenter Network of Neonatal Intensive Care Units | WALSH, MICHELE | CASE WESTERN RESERVE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD021373 | Multicenter Network of Neonatal Intensive Care Units | KENNEDY, KATHLEEN A | UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD021385 | Cooperative Multicenter Network of Neontal Intensive Care Units | SHANKARAN, SEETHA | WAYNE STATE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027851 | Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network | CARLTON, DAVID | EMORY UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027853 | NICHD Cooperative Multicenter Neonatal Research Network | SCHIBLER, KURT R | CINCINNATI CHILDRENS HOSP MED CTR | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027856 | Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network | SOKOL, GREGORY M. | INDIANA UNIVERSITY INDIANAPOLIS | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027880 | NICHD Cooperative Multicenter Neonatal Research Network | VAN MEURS, KRISA PAGE | STANFORD UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
1 to 10 of 21
See all 21 grantsTrial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Hydrocortisone vs Placebo: deaths from any cause | Trial comparisons |
| Hydrocortisone vs Placebo: serious adverse events | Trial comparisons |
Tests0
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01353313
GET https://conductscience.org/api/trials/v1/NCT01353313/registered?page=2