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Work of Breathing in Term Infants

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05209269
Enrollment
31
Registered
2022-01-26
Start date
2022-04-22
Completion date
2023-08-31
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Term Infant, Work of Breathing

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.

Interventions

OTHERWork of breathing observation

We will place soft elastic bands around the infant's chest and abdomen to assess their work of breathing.

Sponsors

Christiana Care Health Services
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Weeks

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.

Design outcomes

Primary

MeasureTime frameDescription
Work of breathing indices25 minutesA 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

MeasureTime frameDescription
Oxygen saturations25 minutesOxygen saturations will be measured by the high-resolution pulse oximeter.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026