Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2026-09-30
2029-03-31
Brief Summary
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Detailed Description
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• To evaluate safety of late surfactant therapy with budesonide in extremely preterm infants.
Secondary Objectives
* To evaluate the oxygenation response to late surfactant therapy with budesonide in extremely preterm infants at 48 hours and 7 days after completion of the study intervention
* To evaluate respiratory outcomes following administration of late surfactant therapy with budesonide
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Premature babies: Study 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 7 days post-intervention)
Calfactant
Participants will receive 2 daily doses of Calfactant (3 ml/kg) intratracheal administration
Budesonide
Participants will receive 2 daily doses of Budesonide (0.25mg/kg) intratracheal administration.
Premature babies: Standard of Care
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)
No interventions assigned to this group
Interventions
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Calfactant
Participants will receive 2 daily doses of Calfactant (3 ml/kg) intratracheal administration
Budesonide
Participants will receive 2 daily doses of Budesonide (0.25mg/kg) intratracheal administration.
Eligibility Criteria
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Inclusion Criteria
* Age 7-14 days
* Need invasive mechanical ventilatory support and a Fraction of Inspired Oxygen (FiO2) greater than or equal to 0.3
* Have a baby who meets neonate eligibility criteria and enrolls in the study.
Exclusion Criteria
* Alternative, acute clinical etiology of respiratory deterioration or increased ventilatory requirements (e.g., sepsis, pneumonia, etc.)
* History of pulmonary hemorrhage
* Antibiotic use within 48 hours
* Indomethacin or Ibuprofen use within 72 hours
* Prior treatment with corticosteroids for prevention of lung disease
* Not expected to survive for greater than 7 days at enrollment
* Determined to be unstable by the clinical team
* Enrolled in a conflicting clinical trial
* Have a birth parent aged less than 18 years
* Parent/guardian is unable to provide parental permission in English or Spanish
7 Days
14 Days
ALL
No
Sponsors
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Meriter Foundation
OTHER
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Dinushan Kaluarachchi, MBBS
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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Meriter Hospital
Madison, Wisconsin, United States
American Family Children's Hospital
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A536757
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\PEDIATRICS\NEONATO
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 10/09/25
Identifier Type: OTHER
Identifier Source: secondary_id
2024-1479
Identifier Type: -
Identifier Source: org_study_id
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