Work of Breathing in Term Infants

Completed

• Conditions: Work of Breathing; Term Infant

• Registration Number: NCT05209269
• Lead Sponsor: Christiana Care Health Services

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-26
• Study Start: 2022-04-22
• Primary Completion: 2023-06-01
• Study Completion: 2023-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Work of breathing indices	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 Outcome Measures

Name	Time	Method
Oxygen saturations	25 minutes	Oxygen saturations will be measured by the high-resolution pulse oximeter.

Trial Locations

Locations (1)

Christiana Care Health Services, Inc.; 🇺🇸 Newark, Delaware, United States