Work of Breathing in Term Infants

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.

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Key information

Conditions

Work of Breathing Term Infant

Age range

1 day–1 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Care Health Services, Inc.

Newark, Delaware, 19718, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Work of breathing observation

Other

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

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

Time frame: 25 minutes

Oxygen saturations will be measured by the high-resolution pulse oximeter.

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jan 26, 2022
Registry last updated: Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed