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| ID | Type | Description | Link |
|---|---|---|---|
| A536757 | Other Identifier | UW Madison | |
| SMPH\PEDIATRICS\NEONATO | Other Identifier | UW Madison | |
| Protocol Version 10/09/25 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Meriter Foundation | OTHER |
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This clinical trial is being done to evaluate the safety and clinical response of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.
Primary Objective
• To evaluate safety of late surfactant therapy with budesonide in extremely preterm infants.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premature babies: Study Intervention | Experimental | Preterm infants born at gestational age less than 29 0/7 weeks requiring mechanical ventilation at 7-14 days of life (targeting N=12 participants completing study to 7 days post-intervention) |
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| Premature babies: Standard of Care | No Intervention | Preterm infants born at gestational age less than 29 0/7 weeks requiring mechanical ventilation at 7-14 days of life (targeting N=12 participants completing study to 10 days post-randomization) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calfactant | Drug | Participants will receive 2 daily doses of Calfactant (3 ml/kg) intratracheal administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Presence or absence of acute clinical deterioration up to 60 minutes after study intervention | Presence or absence of acute clinical deterioration - defined as desaturation less than 80 percent and/or bradycardia less than 100 beats per minute (bpm) - during the study intervention and up to 60 minutes after study intervention. | up to 60 minutes after study intervention (intervention received within 14 days of life (DOL)) |
| Presence or absence of severe acute clinical deterioration up to 60 minutes after study intervention | Presence or absence of severe acute clinical deterioration - defined as desaturation less than 60 percent and/or bradycardia less than 80 bpm - during the study intervention and up to 60 minutes after study intervention. | up to 60 minutes after study intervention (intervention received within 14 DOL) |
| Occurrence of pneumothorax needing evacuation up to 48 hours after completion of study intervention | A yes or no question of whether there was pneumothorax (air in the pleural cavity) detected via chest x-ray, needing evacuation from baseline to 48 hours after completion of study intervention | baseline to 48 hours after completion of study intervention (intervention received within 14 DOL) |
| Occurrence of pulmonary hemorrhages up to 48 hours after completion of study intervention | A yes or no question of whether pulmonary hemorrhage (bleeding in lungs) was observed in the endotracheal tube from baseline to 48 hours after completion of study intervention. | baseline to 48 hours after completion of study intervention (intervention received within 14 DOL) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Respiratory Severity Score (RSS) | RSS is the mean airway pressure multiplied by the fraction of inspired oxygen, a change toward higher scores indicates more severe respiratory symptoms. | Baseline to 7 days post-intervention (intervention received within 14 DOL) |
| Death or Grade 3 Bronchopulmonary Dysplasia (BPD) by 36 0/7 weeks Post-Menstrual Age (PMA) |
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Neonate Inclusion Criteria:
Birthing Parent Inclusion Criteria:
Neonate Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dinushan Kaluarachchi, MBBS | Contact | (608) 417-6849 | kaluarachchi@pediatrics.wisc.edu | |
| Meg Baker | Contact | meg.baker@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dinushan Kaluarachchi, MBBS | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meriter Hospital | Madison | Wisconsin | 53715 | United States |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007752 | Obstetric Labor, Premature |
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| ID | Term |
|---|---|
| C117342 | calfactant |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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This is a phase I/II pilot randomized controlled clinical trial to obtain preliminary data on safety and clinical response of multiple doses of late surfactant treatment with budesonide
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| Budesonide | Drug | Participants will receive 2 daily doses of Budesonide (0.25mg/kg) intratracheal administration. |
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| up to 36 0/7 weeks PMA |
| Days of mechanical ventilation by 36 0/7 weeks PMA | Days of mechanical ventilation by 36 0/7 weeks PMA (If an infant died before 36 0/7 weeks, time from death to 36 0/7 weeks PMA will be considered as mechanical ventilation days) | up to 36 0/7 weeks PMA |
| American Family Children's Hospital | Madison | Wisconsin | 53792 | United States |
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| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |