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| ID | Type | Description | Link |
|---|---|---|---|
| IND79367 | Other Identifier | FDA |
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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
| ONY | INDUSTRY |
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The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.
Surfactant dysfunction may contribute to the development of bronchopulmonary dysplasia (BPD) in persistently ventilated preterm infants. The investigators conducted a multi-center, randomized, blinded pilot study to assess the safety and efficacy of late administration of surfactant (Calfactant - high in protein B) in combination with prolonged inhaled nitric oxide in preterm infants < 1000 grams birthweight (BW). Calfactant is one of several types of exogenous surfactant. Calfactant has the highest % of surfactant protein B of the different types.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Surfactant (Infasurf) ONY, NY | Active Comparator | Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated. |
|
| Sham (no treatment) | Placebo Comparator | Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infasurf (ONY Inc.) | Drug | Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SP-B Content | SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose. | One day after dose |
| Measure | Description | Time Frame |
|---|---|---|
| Alive Without BPD at 36 Weeks Post Menstrual Age | Alive without need for oxygen at 36 weeks post menstrual age. | 36 Weeks Post Menstrual Age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberta A Ballard, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alta Bates Summit Medical Center | Berkeley | California | 94705 | United States | ||
| Children's Hospital Oakland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16870913 | Background | Ballard RA, Truog WE, Cnaan A, Martin RJ, Ballard PL, Merrill JD, Walsh MC, Durand DJ, Mayock DE, Eichenwald EC, Null DR, Hudak ML, Puri AR, Golombek SG, Courtney SE, Stewart DL, Welty SE, Phibbs RH, Hibbs AM, Luan X, Wadlinger SR, Asselin JM, Coburn CE; NO CLD Study Group. Inhaled nitric oxide in preterm infants undergoing mechanical ventilation. N Engl J Med. 2006 Jul 27;355(4):343-53. doi: 10.1056/NEJMoa061088. | |
| 17671061 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Surfactant (Infasurf) ONY, NY | Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated. Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14. |
| FG001 | Sham (no Treatment) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sham | Drug | Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated. |
|
|
| Oakland |
| California |
| 94609 |
| United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Women and Children's Hospital of Buffalo | Buffalo | New York | 14222 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Background |
| Ballard PL, Merrill JD, Truog WE, Godinez RI, Godinez MH, McDevitt TM, Ning Y, Golombek SG, Parton LA, Luan X, Cnaan A, Ballard RA. Surfactant function and composition in premature infants treated with inhaled nitric oxide. Pediatrics. 2007 Aug;120(2):346-53. doi: 10.1542/peds.2007-0095. |
| 17403837 | Background | Truog WE, Ballard PL, Norberg M, Golombek S, Savani RC, Merrill JD, Parton LA, Cnaan A, Luan X, Ballard RA; Nitric Oxide (to Prevent) Chronic Lung Disease Study Investigators. Inflammatory markers and mediators in tracheal fluid of premature infants treated with inhaled nitric oxide. Pediatrics. 2007 Apr;119(4):670-8. doi: 10.1542/peds.2006-2683. |
| 23037875 | Background | Keller RL, Merrill JD, Black DM, Steinhorn RH, Eichenwald EC, Durand DJ, Ryan RM, Truog WE, Courtney SE, Ballard PL, Ballard RA. Late administration of surfactant replacement therapy increases surfactant protein-B content: a randomized pilot study. Pediatr Res. 2012 Dec;72(6):613-9. doi: 10.1038/pr.2012.136. Epub 2012 Oct 4. |
Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated. Sham Infants will not receive additional doses of Infasurf. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Surfactant (Infasurf) ONY, NY | Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated. Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14. |
| BG001 | Sham (no Treatment) | Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated. Sham Infants will not receive additional doses of Infasurf. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at enrollment: Infants were enrolled if they remained ventilated between 7 and 14 day of age. | Mean | Standard Deviation | Days |
| ||||||||||||||
| Sex/Gender, Customized | Number | infants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | infants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | infants |
| ||||||||||||||||
| Region of Enrollment | Number | infants |
| ||||||||||||||||
| Antenatal Corticosteroids | Number of infants who received Antenatal Corticosteroids. Not all mothers receive antenatal steroids. Therefore number treated will not match number in group. | Number | infants |
| |||||||||||||||
| Prior surfactant treatment | Number of infants who received prior surfactant therapy (prior to enrollment). Not all infants receive surfactant therapy at birth. Therefore number treated will not always match number in group. | Number | infants |
| |||||||||||||||
| RSS at entry | Respiratory Severity Score = Mean Airway pressure X FiO2. The higher the number, the sicker the infant. | Mean | Standard Deviation | cm H2O |
| ||||||||||||||
| Multiple gestation | The number of infants who were a product of a multiple gestation pregnancy. Only a small number of pregnancies are multiple gestation. Multiple gestation infants will be a subset of infants enrolled. | Number | infants |
|
| 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 | SP-B Content | SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose. | 24 of 43 in the Treatment Group and 18 of 42 in the Sham group had samples analyzed. SpB content recorded as a percentage of Total Phospholipids. | Posted | Mean | Full Range | Total surfactant protein (% of PL) | One day after dose |
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| ||||||||||||||||||||||||||||
| Secondary | Alive Without BPD at 36 Weeks Post Menstrual Age | Alive without need for oxygen at 36 weeks post menstrual age. | Posted | Number | Number of infants | 36 Weeks Post Menstrual Age |
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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 | Treatment Surfactant (Infasurf) ONY, NY | Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated. Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14. | 0 | 43 | 0 | 43 | ||
| EG001 | Sham (no Treatment) | Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated. Sham Infants will not receive additional doses of Infasurf. | 0 | 42 | 0 | 42 |
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More frequent dosing, with the resultant improvements in lung function, may allow for more rapid weaning from mechanical ventilation, leading to improved pulmonary outcomes, both short-term and long-term. Modifications to protocol being investigated.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberta R. Keller, MD | University of California, San Francisco | 415-514-3192 | roberta.keller@ucsf.edu |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| C580477 | Surfactant Dysfunction |
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C117342 | calfactant |
| C005703 | salicylhydroxamic acid |
| D000388 | Air |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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