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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TERMINATED
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2016-04-11
2018-08-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Positive end-expiratory pressure (PEEP) level changes
Sequential changes in PEEP level within range of 4-8 cm H2O followed by measurement of V/Q mismatch at each level.
Positive end-expiratory pressure (PEEP)
level changes as per arm description
Interventions
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Positive end-expiratory pressure (PEEP)
level changes as per arm description
Eligibility Criteria
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Inclusion Criteria
2. Birth weight less than 1500 grams, as measured by the clinical team at neonatal admission.
3. Presence of endotracheal intubation and invasive mechanical ventilation
4. Less than or equal to 28 days chronologic age
5. Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) equal to or greater than 0.25 as documented on the bedside infant flow sheet.
Exclusion Criteria
2. Current of prior air leak syndrome, as determined by the clinical supervising physician.
3. Non-English speaking parents
4. Non-viable birth, as determined by the clinical supervising physician
0 Days
28 Days
ALL
No
Sponsors
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Christiana Care Health Services
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Haresh Kirpalani, BM, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Christiana Care Health System
Newark, Delaware, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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17-013702
Identifier Type: -
Identifier Source: org_study_id