Work of Breathing in Term Infants

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05209269
• Other study ID #: DDD605112
• Status: Completed
• Start date: April 22, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2023
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 31, 2023
• Est. primary completion date: June 1, 2023
• 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.

Related Conditions & MeSH terms

• Respiratory Aspiration
• Term Infant
• Work of Breathing

Intervention

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

Locations

Country	Name	City	State
United States	Christiana Care Health Services, Inc.	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

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