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Premature infants frequently have trouble breathing after birth. If the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the infant through a tube inserted into the windpipe. This study will compare the safety of two of the commonly used surfactants, poractant and calfactant,in the United States. Poractant has added chemicals called phospholipids which are known to cause inflammation and irritation in the body of premature infants. The investigators will compare this to another similar surfactant that does not contain these chemicals by looking at samples from the windpipe, while the tube is in place, and from blood tests in the first few days of life.
The investigators are hoping to learn whether calfactant is a safer therapeutic agent to treat respiratory distress syndrome in preterm infants compared to poractant.
30 infants were randomized to receive either poractant or calfactant for Respiratory Distress Syndrome.
Tracheal aspirates were obtained to look for increase in macrophage and blood samples were drawn to look for markers of inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calfactant | Active Comparator | Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. |
|
| Poractant Alfa | Active Comparator | Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poractant alfa | Drug | Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Blood C-reactive (CRP) Protein | Difference between measurement of CRP at baseline and 48 hours after administration of surfactant | baseline, 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Pulmonary Hemorrhage | Significant and Persistent Blood present in the trachea during endotracheal tube suctioning. | intraoperative |
| Change in Number of Tracheal Macrophages | measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naomi Lauriello, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri, Women's and Children's Hospital | Columbia | Missouri | 65201 | United States |
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Infants < 35 weeks gestation requiring intubation and surfactant for Respiratory Distress Syndrome. Infants with suspected congenital infection, major birth defects, known chromosomal disorder, cord blood pH < 7.0, or Apgar score of 3 or < at 10 minutes were excluded. The infants were randomized to receive either Poractant or Calfactant.
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| ID | Title | Description |
|---|---|---|
| FG000 | Poractant | Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. |
| FG001 | Calfactant | Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Preterm infants less than 35 weeks gestation who required intubation for RDS and surfactant administration
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| ID | Title | Description |
|---|---|---|
| BG000 | Poractant | Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. |
| BG001 | Calfactant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change From Baseline in Blood C-reactive (CRP) Protein | Difference between measurement of CRP at baseline and 48 hours after administration of surfactant | Posted | Mean | Standard Deviation | mg/dL | baseline, 48 hours |
|
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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 | Calfactant | Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. calfactant: Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Naomi Lauriello | University of Missouri-Columbia | 573-882-2272 | lauriellon@health.missouri.edu |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C068291 | poractant alfa |
| C117342 | calfactant |
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|
| calfactant | Drug | Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist |
|
|
| baseline, 48 hours |
Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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|
|
| Secondary | Presence of Pulmonary Hemorrhage | Significant and Persistent Blood present in the trachea during endotracheal tube suctioning. | This data is unavailable from the research department as it was not collected. | Posted | intraoperative |
|
|
| Secondary | Change in Number of Tracheal Macrophages | measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate | Posted | Mean | Standard Deviation | white cells/high-powered field | baseline, 48 hours |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Poractant Alfa | Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. Poractant alfa: Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |