Work of Breathing Clinical Trial
Official title:
Comparing Oxygen Saturation Stability and Work of Breathing Between Normal Term Infants and Premature Infants Prior to Discharge
NCT number | NCT05209269 |
Other study ID # | DDD605112 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 22, 2022 |
Est. completion date | August 31, 2023 |
Verified date | September 2023 |
Source | Christiana Care Health Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a prospective observational cohort study conducted in the mother-baby unit at ChristianaCare. The study is designed to assess work of breathing indices and oxygen saturation stability at discharge in full-term infants. Data obtained will be used to perform a comparative analysis on work of breathing data for premature infants obtained from our previous study. We hypothesize full term (≥37 weeks gestation) infants have decreased work of breathing indices (i.e., phase angle) compared to premature infants (born 26-37 weeks gestation) at discharge.
Status | Completed |
Enrollment | 31 |
Est. completion date | August 31, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 1 Day to 1 Week |
Eligibility | Inclusion Criteria: - Infants born =37 weeks gestation - Admitted to the Mother-Baby Unit - Within 24 hours of expected discharge Exclusion Criteria: - Infants born between < 37week gestation admitted to the Mother-Baby Unit at CCHS - Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of work of breathing measurements will also be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Christiana Care Health Services, Inc. | Newark | Delaware |
Lead Sponsor | Collaborator |
---|---|
Christiana Care Health Services |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Work of breathing indices | A phase angel of 0 represents perfect synchrony between the chest and abdominal compartments. Higher phase angles represent greater degrees of asynchronous breathing. A phase angle of = 40 represents asynchrony and increased work of breathing. A phase angle of 180 represents complete asynchrony. | 25 minutes | |
Secondary | Oxygen saturations | Oxygen saturations will be measured by the high-resolution pulse oximeter. | 25 minutes |
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