Study Results
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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COMPLETED
29 participants
OBSERVATIONAL
2018-11-01
2020-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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all infants
There will be one arm for this study. All infants will receive a similar intervention during their routine kangaroo mother care (KMC). KMC is a national and international standard of care. This is an observational study of how infants breath while participating in KMC compared to how they breath while in a crib or incubator. Work of breathing will be measured at baseline and then during KMC. Mothers will participate in KMC regardless of participation in the study. Work of breathing will be measured by using Respiratory Inductance Plethysmography (RIP). This scientifically measures work of breathing (specifically phase angles) by placing soft bands around the abdomen and chest. The actual "intervention" is a standard of care and something that the mother infant dyad will do regardless of the study. Each mother / infants pair is expected to be actively enrolled for approximately 2 hours.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Respiratory insufficiency
* \>4d PMA
* Stable and receiving non-invasive respiratory support for ≥12 hours (NC, HFNC or CPAP)
* Requiring ≤40% supplemental FiO2
Exclusion Criteria
* Infants who do not meet criteria to participate in kangaroo mother care
4 Days
6 Months
ALL
No
Sponsors
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Christiana Care Health Services
OTHER
Responsible Party
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Principal Investigators
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Kelley Kovatis, MD
Role: STUDY_DIRECTOR
Christiana Care Health Services
Locations
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Christiana Care Health Services, Inc
Newark, Delaware, United States
Countries
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Other Identifiers
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DDD603995
Identifier Type: -
Identifier Source: org_study_id
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