N/A
N=12
Impact of CPAP Level on V/Q Mismatch in Premature Infants
Infant, Premature, Diseases · Respiratory Insufficiency Syndrome of Newborn
Bottom Line
View on ClinicalTrials.gov: NCT02983825 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Ventilation/Perfusion Mismatch — 1.2 difference in right shift (kPa) — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous positive airway pressure (CPAP); level changes (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ventilation/Perfusion Mismatch |
1.2 | 0.02 sig |
| SECONDARY Best CPAP Level |
7 | — |
Summary
Continuous positive airway pressure (CPAP) is used in premature infants to maintain lungs open and facilitate gas exchange. When ventilation/perfusion (V/Q) mismatch is present, areas of the lung that are open for gas exchange do not match up with the areas of the lung that are receiving blood for gas exchange. This study measure the responsiveness of V/Q mismatch to changes in the amount (or level) of CPAP.
Eligibility Criteria
Inclusion Criteria
- Born at 27-35 weeks gestational age (GA) by best obstetric estimate, determined by the clinical obstetric team during antepartum admission.
- Age limits: 24 hours of age - 35 weeks corrected gestational age.
- On continuous CPAP support between 4-8 cm H2O for greater than 24 hours, as document on the bedside infant flow sheet.
- Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) 0.25 for at least 2 consecutive hours, as documented on the bedside infant flow sheet.
Exclusion Criteria
- Congenital anomalies, as determined by the clinical supervising physician.
- Current or prior air leak syndrome, as determined by the clinical supervising physician.
Data sourced from ClinicalTrials.gov (NCT02983825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.