Work of Breathing in Term Infants

NCT05209269 | Completed

• 1 other identifier: DDD605112
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Work of Breathing; Term Infant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Oxygen saturations

  25 minutes

Interventions

Work of breathing observation OTHER

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

Eligibility Criteria

• Age: 1 Day - 1 Week
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants born ≥37 weeks gestation admitted to the Mother-Baby Unit

You may qualify if:

• Infants born ≥37 weeks gestation
• Admitted to the Mother-Baby Unit
• Within 24 hours of expected discharge

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health Services, Inc.

Newark, Delaware, 19718, United States

Location

Study Officials

• Kelley Z Kovatis, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: April 22, 2022
• Primary Completion: June 1, 2023
• Study Completion: August 31, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)