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Slow recruitment,changes in protocols, larger than anticipated differences
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| Name | Class |
|---|---|
| Dey LP | UNKNOWN |
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Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates.
The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.
Specific Aims:
We reasoned that if Curosurf was primarily responsible for improved survival rates, compared with Survanta, then there should be a sustained improvement in respiratory function in the first three days of life, when the direct pulmonary effects of the surfactant preparations would be most easily detected. It was also possible that Curosurf and Survanta could have effects on other systems that could secondarily affect long-term survival of the infant. These other organ systems would include, but not be limited to, the development of a hemodynamically significant Patent Ductus Arteriosus, Intraventricular Hemorrhage or Periventricular Leukomalacia, or Necrotizing Enterocolitis. We propose to examine how surfactant administration affected the hemodynamic precursors of these common morbidities of very premature infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Surfactant (beractant, Survanta initial dose 100 mg/kg and subsequent doses 100 mg/kg phospholipids every 6-12 hours, as needed for up to 4 doses), intratracheal administration to very premature infants with RDS requiring mechanical ventilation |
|
| 2 | Experimental | Surfactant (poractant, Curosurf initial dose 200 mg/kg and subsequent doses 100 mg/kg phospholipids every 12-24 hours as needed for up to 3 doses), intratracheal administration to very premature infants with RDS requiring mechanical ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survanta (beractant) | Drug | beractant 4.0 ml/kg/dose (100 mg phospholipid/kg/dose, intratracheal, every 6-12 hours as needed for respiratory distress syndrome for initial and subsequent doses, maximum of 4 doses) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration. | Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team. | 48 hours after surfactant administration |
| Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration | Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 72 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while oxygen concentration was controlled by the clinical team. | 72 hours after surfactant administration |
| Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration. | Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 48 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect. | 48 hours after surfactant administration |
| Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration. | Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 72 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups | Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 48 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups. | 48 hours after surfactant administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan M Fujii, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Fujii AM, Editorial. Is There Really A Clinical Difference In Surfactant Preparations? J Perinatol 2010; 30:698; doi:10,1038/jp.2010.90 | ||
| Background | Fujii A. Editorial. Are all animal derived surfactants the same? The e-NeoResearch 2011; 1 (1); 50-51. | ||
| 19956811 | Result | Fujii AM, Carillo M. Animal-derived surfactant treatment of respiratory distress syndrome in premature neonates: a review. Drugs Today (Barc). 2009 Sep;45(9):697-709. doi: 10.1358/dot.2009.45.9.1418185. | |
| 20336076 |
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Patients born between 1/2005 and 5/2008 with respiratory distress syndrome requiring mechanical ventilation, <30 weeks gestation, greater than 500 g and whose parents provided informed consent were included in the study. Infants with multiple congenital anomalies, significant congenital heart disease were excluded.
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| ID | Title | Description |
|---|---|---|
| FG000 | Beractant Arm | Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals) |
| FG001 | Poractant Alfa Arm | Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Beractant Arm | Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals) |
| BG001 | Poractant Alfa Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The population is recruited from premature infants with Respiratory Distress Syndrome on the first day of life. |
| 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 | Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration. | Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team. | Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis. | Posted | Jun 2011 | Mean | Standard Error | cm H20 | 48 hours after surfactant administration |
|
Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age.
Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death
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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 | Beractant Arm | Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | Death before NICU discharge |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopulmonary Dysplasia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Oxygen requirement at 36 weeks Post menstrual age in infants surviving to 36+ weeks. |
The primary limitations are the small number of patients, the high rate of chronic lung disease in the beractant group and the open-label design of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Fujii MD (PI) | Boston Medical Center | 617-4414-3735 | Alan.Fujii@bmc.org |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012128 | Respiratory Distress Syndrome |
| D004374 | Ductus Arteriosus, Patent |
| 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 |
|---|---|
| C072197 | beractant |
| C068291 | poractant alfa |
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|
| Curosurf (poractant) | Drug | poractant alfa 2.5 ml/kg/dose initial (200 mg phospholipid/kg), and 1.25 ml/kg/dose subsequent (100 mg/kg/subsequent dose), intratracheal, every 12-24 hours as needed for respiratory distress syndrome, maximum of 3 doses) |
|
|
| 72 hours after surfactant administration |
| Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups | Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 72 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups. | 72 hours after surfactant administration |
| Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant) | Hemodynamically significant PDA, considered significant by the clinical team and having at least 2 objective echocardiographic signs (PDA > 1.5 mm diameter, retrograde diastolic flow in the descending aorta, and left atrial enlargement) were tallied. Hemodynamically significant PDA may increase lung water and decrease lung compliance, requiring increased mechanical ventilator support. | Hemodynamically significant PDA at > 2 days |
| Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf) | Maximal changes in blood flow were assessed using Doppler echocardiography following the second surfactant dose of Survanta (beractant) or Curosurf (poractant alfa), to determine whether there was a direct effect of surfactant type on PDA size or pulmonary volume overload through the PDA. The hour interval following the second surfactant dose was selected for study, when the subjects were otherwise clinically stable, not needing additional stabilization procedures. | First hour after 2nd surfactant dose |
| Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant | Percent change in Anterior Cerebral Artery blood flow velocity following the second dose of beractant, reflects the change in brain blood flow associated with surfactant administration. Blood flow velocity is measured by range gated Doppler ultrasound and brain blood flow changes in proportion to changes in arterial carbon dioxide levels, induced by surfactant administration. Variability in brain blood flow is associated with increased risk for intraventricular hemorrhage. | One hour following second surfactant dose at 12-24 hours after initial dose |
| Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) | Patients with Bronchopulmonary Dysplasia (BPD), had chronic lung disease requiring supplemental oxygen support at >/= 36 weeks post menstrual age, were tallied. BPD is a chronic lung disease that develops, at least in part, as a consequence of NICU respiratory management of premature infants with Respiratory Distress Syndrome. | 36 weeks post menstrual age |
| Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU. | Bronchopulmonary Dysplasia + death outcome for all patients enrolled in the study were tallied and used to determine whether neonatal death decreased the frequency of chronic lung disease in one group vs the other. | NICU hospitalization, up to 42 weeks post menstrual age |
| Result |
| Fujii AM, Patel SM, Allen R, Doros G, Guo CY, Testa S. Poractant alfa and beractant treatment of very premature infants with respiratory distress syndrome. J Perinatol. 2010 Oct;30(10):665-70. doi: 10.1038/jp.2010.20. Epub 2010 Mar 25. |
| 20336077 | Result | Fujii A, Allen R, Doros G, O'Brien S. Patent ductus arteriosus hemodynamics in very premature infants treated with poractant alfa or beractant for respiratory distress syndrome. J Perinatol. 2010 Oct;30(10):671-6. doi: 10.1038/jp.2010.21. Epub 2010 Mar 25. |
| Result | Fujii AM, Bailey J, Doros G, Sampat K, Sikes NC, Mason M, Kaiser JR. Cerebral Blood Flow Responses to Beractant and Poractant Administration. Journal of Neonatal-Perinatal Medicine 2009; 2:27-34 |
Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses) |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational Age in weeks | All patients are enrolled on the first day of life. Therefore the mean +/- SD = 0 +/- 0 years. | Mean | Standard Deviation | weeks |
|
| OG001 | Poractant Alfa Arm | Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses) |
|
|
|
| Secondary | Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups | Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 48 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups. | Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure. | Posted | Jun 2011 | Number | 90% Confidence Interval | Participants successfully extubated | 48 hours after surfactant administration |
|
|
|
|
| Primary | Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration | Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 72 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while oxygen concentration was controlled by the clinical team. | Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis. | Posted | Jun 2011 | Mean | Standard Error | cm H20 | 72 hours after surfactant administration |
|
|
|
|
| Secondary | Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups | Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 72 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups. | Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure. | Posted | Jun 2011 | Number | 90% Confidence Interval | Participants successfully extubated | 72 hours after surfactant administration |
|
|
|
|
| Secondary | Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant) | Hemodynamically significant PDA, considered significant by the clinical team and having at least 2 objective echocardiographic signs (PDA > 1.5 mm diameter, retrograde diastolic flow in the descending aorta, and left atrial enlargement) were tallied. Hemodynamically significant PDA may increase lung water and decrease lung compliance, requiring increased mechanical ventilator support. | Patients with clinically and hemodynamically significant Patent Ductus Arteriosus, on evaluation at >3 days, were tallied | Posted | Jun 2011 | Number | 90% Confidence Interval | Subjects | Hemodynamically significant PDA at > 2 days |
|
|
|
|
| Secondary | Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf) | Maximal changes in blood flow were assessed using Doppler echocardiography following the second surfactant dose of Survanta (beractant) or Curosurf (poractant alfa), to determine whether there was a direct effect of surfactant type on PDA size or pulmonary volume overload through the PDA. The hour interval following the second surfactant dose was selected for study, when the subjects were otherwise clinically stable, not needing additional stabilization procedures. | Population was limited to those subjects with PDA's who were treated with a second dose of surfactant, when the subjects were hemodynamically stable enough to yield meaning data. | Posted | Apr 2011 | Mean | Standard Error | cc/min | First hour after 2nd surfactant dose |
|
|
|
|
| Primary | Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration. | Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 48 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect. | Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis. | Posted | Jun 2011 | Mean | Standard Error | cm H20-Percent of O2 | 48 hours after surfactant administration |
|
|
|
|
| Primary | Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration. | Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 72 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect. | Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis. | Posted | Jun 2011 | Mean | Standard Error | cm H20-Percent of O2 | 72 hours after surfactant administration |
|
|
|
|
| Secondary | Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant | Percent change in Anterior Cerebral Artery blood flow velocity following the second dose of beractant, reflects the change in brain blood flow associated with surfactant administration. Blood flow velocity is measured by range gated Doppler ultrasound and brain blood flow changes in proportion to changes in arterial carbon dioxide levels, induced by surfactant administration. Variability in brain blood flow is associated with increased risk for intraventricular hemorrhage. | The population analyzed was limited to subjects that received second dose of surfactant and were clinically stable enough to allow Doppler assessment of cerebral blood flow during the first hour following surfactant administration. | Posted | Jun 2011 | Mean | Standard Error | Percent change from baseline velocity | One hour following second surfactant dose at 12-24 hours after initial dose |
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| Secondary | Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) | Patients with Bronchopulmonary Dysplasia (BPD), had chronic lung disease requiring supplemental oxygen support at >/= 36 weeks post menstrual age, were tallied. BPD is a chronic lung disease that develops, at least in part, as a consequence of NICU respiratory management of premature infants with Respiratory Distress Syndrome. | Population analyzed was limited to those subjects who survived to >36 weeks post menstrual age. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at >36 weeks post menstrual age) were tallied. | Posted | Jun 2011 | Number | 90% Confidence Interval | Surviving Subjects with BPD | 36 weeks post menstrual age |
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| Secondary | Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU. | Bronchopulmonary Dysplasia + death outcome for all patients enrolled in the study were tallied and used to determine whether neonatal death decreased the frequency of chronic lung disease in one group vs the other. | All subjects enrolled were included. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at > 36 weeks post menstrual age) and patients who expired before discharge from the NICU were tallied. | Posted | Jun 2011 | Number | 90% Confidence Interval | Subjects with BPD + Neonatal Deaths | NICU hospitalization, up to 42 weeks post menstrual age |
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|
|
| 19 |
| 27 |
| 17 |
| 27 |
| EG001 | Poractant Alfa Arm | Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses) | 9 | 25 | 8 | 25 |
| Necrotizing Enterocolitis | Gastrointestinal disorders | Systematic Assessment | Stage 2 Necrotizing enterocolitis |
|
| Severe Intraventricular Hemorrahge (Grade 3-4) | Nervous system disorders | Systematic Assessment |
|
| Significant Pulmonary Hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pulmonary hemorrhage associated with an increase in respiratory support |
|
| ROP Stage II-IV | Eye disorders | Systematic Assessment | Retinopathy of Prematurity at threshold, treated with Laser |
|
|
| Patent Ductus Arteriosus ligation | Cardiac disorders | Systematic Assessment | PDA requiring surgical ligation |
|
| Pulmonary Air Leak | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pulmonary air leak including: pulmonary interstitial emphysema, pneumothorax, pneumatocele |
|
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| D000091642 | Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Change in PDA Flow, following surfactant (cc/min) |
|
| Peak Change in Blood Flow Velocity (cm/sec) |
|
| Percent Change in Blood Flow Velocity (%) |
|