Work of Breathing in Term Infants

NCT ID: NCT05209269

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-22

Study Completion Date

2023-08-31

Brief Summary

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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

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Conditions

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Work of Breathing Term Infant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Work of breathing observation

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Week

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kelley Z Kovatis, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

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Christiana Care Health Services, Inc.

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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DDD605112

Identifier Type: -

Identifier Source: org_study_id

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