Infant, Premature, Diseases, Respiratory Insufficiency Syndrome of Newborn
Conditions
Keywords
Positive end-expiratory pressure, PEEP, Bronchopulmonary Dysplasia, Ventilator Induced Lung Injury, V/Q mismatch
Brief summary
Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical ventilation to maintain lungs open and facilitate gas exchange. When ventilation/perfusion mismatch is present, areas of the lung that are open for gas exchange do not match up with areas of the lung that are receiving blood for gas exchange. This study measures the feasibility of enrolling and completing study maneuvers in premature infants for a prospective study measuring the responsiveness of V/Q mismatch to changes in the amount (or level) of PEEP.
Interventions
level changes as per arm description
Sponsors
Christiana Care Health Services
Children's Hospital of Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
1. Preterm birth before 32 weeks gestational age by best obstetric estimate, determined by the clinical obstetric team during antepartum admission 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
1. Congenital anomalies, as determined by the clinical supervising physician 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility assessed by rate of successfully study enrollment and completion | Full enrollment (12 subjects) | Rate of successfully study enrollment and completion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilation/perfusion mismatch | 10-20 minutes following each PEEP level change | Measured by non-invasive computerized technique based of curvilinear characteristics generated by a best-fit curve connection the fractional inspired oxygen and corresponding peripheral oxygen saturation pairs |
Countries
United States
Outcome results
None listed