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Clinical Trials/NCT05209269
NCT05209269
Completed
Not Applicable

Comparing Oxygen Saturation Stability and Work of Breathing Between Normal Term Infants and Premature Infants Prior to Discharge

Christiana Care Health Services1 site in 1 country31 target enrollmentApril 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Work of Breathing
Sponsor
Christiana Care Health Services
Enrollment
31
Locations
1
Primary Endpoint
Work of breathing indices
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 22, 2022
End Date
August 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Work of breathing indices

Time Frame: 25 minutes

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.

Secondary Outcomes

  • Oxygen saturations(25 minutes)

Study Sites (1)

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