Trial · NCT00233324
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
NCT00233324, Phase 3, Completed, NICHD Neonatal Research Network; results first posted 2014-12-05
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ConductScience Library. Surfactant Positive Airway Pressure and Pulse Oximetry Trial. Trials, record NCT00233324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00233324
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Surfactant Positive Airway Pressure and Pulse Oximetry Trial
- NCT number
- NCT00233324
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,316 participants, actual
- Lead sponsor
- NICHD Neonatal Research Network
- Conditions
- Infant, Newborn, Diseases, Other Preterm Infants, Infant, Small for Gestational Age, Premature Birth, Bronchopulmonary Dysplasia, Retinopathy of Prematurity
- Interventions
- Surfactant, Continuous Positive Airway Pressure (CPAP), Supplemental oxygen with target saturation of 85 to 89%, Supplemental oxygen with target saturation of 91 to 95%
- First posted
- 2005-10-05
- Last updated
- 2019-04-18
- Results first posted
- 2014-12-05
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival Without Bronchopulmonary Dysplasia (BPD) | 36 weeks | |
| Primary | Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) | 55 weeks | |
| Secondary | Death or Neurodevelopmental Impairment | 18-22 months | |
| Secondary | Duration of Mechanical Ventilation | Entire NICU stay, up to 120 days | The length in days that an individual was on mechanical ventilation which includes high frequency and conventional ventilation. |
| Secondary | Survival Without Ventilation | From birth through first 7 days of life. | Surviving the first 7 days of life without any need for ventilation by day 7 |
| Secondary | Received Surfactant Treatment | From birth through 120 days of life. | Received any surfactant treatment. |
| Secondary | Number of Participants With Air Leaks | From birth through first 14 days of life. | Number of participants with air leaks including pnemothorax, pulmonary interstitial emphysema (PIE), and pneumopericardium. |
| Secondary | Physiological Bronchopulmonary Dysplasia | 36 weeks post menstrual age. | Infants who received support via ventilator or CPAP at 36 weeks PMA. Alternatively, infants who received low levels of supplemental oxygen (\<30%) at 36 weeks PMA may have been eligible for a physiologic challenge in which there was an attempt to wean the infant to room air. Specifically, infants were eligible for the challenge if at 36 weeks PMA if they were receiving effective oxygen \<27% and had majority saturation \>90%, or they were receiving effective oxygen 27-30% and had majority saturation \>96%, or they were receiving room air by nasal cannula. The challenge took place between 36 and 37 weeks PMA. Those who were not challenged because their level of support increased (support with CPAP or ventilation or increased oxygen) were considered to have BPD, as were those who failed the challenge. |
| Secondary | Death | 18-22 months | Participants who died by their follow-up visit at 18-22 months. |
| Secondary | Severe Intraventricular Hemorrhage (IVH) | From birth through first 120 days of life. | There are four grades of intraventricular hemorrhage: Grade I - echodensity/hemorrhage is confied to the germinal matrix. Grade II - echodensity/hemorrhage in the lateral ventricle(s) without distention. Grade III - echodensity/hemorrhage in the lateral ventricle(s) with distention. Grade IV - echodense lesion in the parenchyma. Severe IVH is defined as having IVH grades of III or IV. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Survival Without Bronchopulmonary Dysplasia (BPD) | 36 weeks | Participants | NUMBER | |
| PRIMARY | Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) | 55 weeks | 49 infants in the lower oxygen saturation group and 46 infants in the higher oxygen saturation group that had unknown retinopathy of prematurity outcome | participants | NUMBER |
| SECONDARY | Death or Neurodevelopmental Impairment | 18-22 months | participants | NUMBER | |
| SECONDARY | Duration of Mechanical Ventilation | Entire NICU stay, up to 120 days | 1078 participants survived to discharge and they all had information available for regarding use of mechanical ventilation. | days | MEDIAN |
| SECONDARY | Survival Without Ventilation | From birth through first 7 days of life. | 1307 participants had known survival and ventilation statuses. 9 participants were excluded due to unknown ventilation status from birth through 7 days of life: 6 infants in the lower oxygen group, 3 infants in the high oxygen group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Received Surfactant Treatment | From birth through 120 days of life. | 1312 participants had known surfactant treatment. 4 were excluded due to unknown surfactant treatment: 2 infants in the low oxygen group, 2 infants in the high oxygen group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Air Leaks | From birth through first 14 days of life. | All 1316 participants had data on incidence of air leaks. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Physiological Bronchopulmonary Dysplasia | 36 weeks post menstrual age. | 1108 participants survived to 36 weeks and had BPD information. 208 participants did not survive to 36 weeks and were excluded: 114 from the low oxygen group, 94 from the high oxygen group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Death | 18-22 months | 1281 participants with confirmed deaths or survivals by follow-up. 35 were excluded due to incomplete follow-up visits: 21 in low oxygen group, 14 in high oxygen group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Severe Intraventricular Hemorrhage (IVH) | From birth through first 120 days of life. | 1270 participants had known IVH grades. 46 were excluded due to unknown IVH status: 24 infants from the low oxygen group, 22 infants from high oxygen group. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Survival Without Bronchopulmonary Dysplasia (BPD) | CPAP | 346 | Participants | ||
| Survival Without Bronchopulmonary Dysplasia (BPD) | Surfactant | 320 | Participants | ||
| Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) | Lower Oxygen Saturation Target | 434 | participants | ||
| Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) | Higher Oxygen Saturation Target | 418 | participants | ||
| Death or Neurodevelopmental Impairment | CPAP | 173 | participants | ||
| Death or Neurodevelopmental Impairment | Surfactant | 183 | participants | ||
| Death or Neurodevelopmental Impairment | Lower Oxygen Saturation Target | 185 | participants | ||
| Death or Neurodevelopmental Impairment | Higher Oxygen Saturation Target | 171 | participants | ||
| Duration of Mechanical Ventilation | Surfactant and Low Oxygen | 11 | Inter-Quartile Range 2 to 32 | days | |
| Duration of Mechanical Ventilation | Surfactant and High Oxygen | 13 | Inter-Quartile Range 2 to 37 | days |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study | STARTED | Early Surfactant and Lower Range Oxygen | 318 | |
| Main Study | STARTED | Early Surfactant and Higher Range Oxygen | 335 | |
| Main Study | STARTED | CPAP and Lower Range Oxygen | 336 | |
| Main Study | STARTED | CPAP and Higher Range Oxygen | 327 | |
| Main Study | COMPLETED | Early Surfactant and Lower Range Oxygen | 250 | |
| Main Study | COMPLETED | Early Surfactant and Higher Range Oxygen | 275 | |
| Main Study | COMPLETED | CPAP and Lower Range Oxygen | 274 | |
| Main Study | COMPLETED | CPAP and Higher Range Oxygen | 280 | |
| Main Study | NOT COMPLETED | Early Surfactant and Lower Range Oxygen | 68 | |
| Main Study | NOT COMPLETED | Early Surfactant and Higher Range Oxygen | 60 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events40
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 | Nasal Breakdown | Respiratory, thoracic and mediastinal disorders | Surfactant and Lower Range Oxygen | 4 | 318 | |
| other | Nasal Breakdown | Respiratory, thoracic and mediastinal disorders | Surfactant and Higher Range Oxygen | 3 | 335 | |
| other | Nasal Breakdown | Respiratory, thoracic and mediastinal disorders | CPAP and Lower Range Oxygen | 10 | 336 | |
| other | Nasal Breakdown | Respiratory, thoracic and mediastinal disorders | CPAP and Higher Range Oxygen | 6 | 327 | |
| other | Any other non-serious adverse event | General disorders | Surfactant and Lower Range Oxygen | 0 | 318 | |
| other | Any other non-serious adverse event | General disorders | Surfactant and Higher Range Oxygen | 2 | 335 | |
| other | Any other non-serious adverse event | General disorders | CPAP and Lower Range Oxygen | 1 | 336 | |
| other | Any other non-serious adverse event | General disorders | CPAP and Higher Range Oxygen | 1 | 327 | |
| serious | Death | General disorders | Surfactant and Lower Range Oxygen | 68 | 318 | |
| serious | Death | General disorders | Surfactant and Higher Range Oxygen | 60 | 335 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Surfactant and Lower Range Oxygen | ||
| Total, all-cause mortality | Surfactant and Higher Range Oxygen | ||
| Total, all-cause mortality | CPAP and Lower Range Oxygen | ||
| Total, all-cause mortality | CPAP and Higher Range Oxygen | ||
| Total, other adverse events | Surfactant and Lower Range Oxygen | 4 | 318 |
| Total, other adverse events | Surfactant and Higher Range Oxygen | 5 | 335 |
| Total, other adverse events | CPAP and Lower Range Oxygen | 11 | 336 |
| Total, other adverse events | CPAP and Higher Range Oxygen | 7 | 327 |
| Total, serious adverse events | Surfactant and Lower Range Oxygen | 204 | 318 |
| Total, serious adverse events | Surfactant and Higher Range Oxygen | 227 | 335 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers19
The papers the trial lists on ClinicalTrials.gov.
Grants30
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| U10HD027904 | NICHD Cooperative Multicenter Neonatal Research Network | LAPTOOK, ABBOT R | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD034216 | Cooperative Multicenter Neonatal Research Network - UAB | CARLO FONT, WALDEMAR A. | UNIVERSITY OF ALABAMA AT BIRMINGHAM | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1996 to 2015 | NIH RePORTER |
1 to 10 of 30
See all 30 grantsTrial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lower Oxygen Saturation Target vs Higher Oxygen Saturation Target: Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) | Trial comparisons |
| CPAP vs Surfactant: Survival Without Bronchopulmonary Dysplasia (BPD) | 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/NCT00233324
GET https://conductscience.org/api/trials/v1/NCT00233324/results?page=2