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Clinical Trials/NCT03683316
NCT03683316CompletedNot Applicable

The Impact of Kangaroo Mother Care on Work of Breathing Indices and Oxygen Saturation Stability in Very Low Birth Weight Infants

Christiana Care Health Services1 site in 1 country29 target enrollmentStarted: November 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
29
Locations
1
Primary Endpoint
Change in work of breathing

Study Overview

Brief Summary

To compare work of breathing and oxygen saturation before, during, and after kangaroo mother care in preterm very low birth weight (VLBW) infants stable on non-invasive respiratory support.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
4 Days to 6 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Very low birth weight infants (those less than 1500g at birth)
  • Respiratory insufficiency
  • Stable and receiving non-invasive respiratory support for ≥12 hours (NC, HFNC or CPAP)
  • Requiring ≤40% supplemental FiO2

Exclusion Criteria

  • Infants with skeletal, neuromuscular or abdominal surgical disorders that may affect the accuracy of work of breathing measurements
  • Infants who do not meet criteria to participate in kangaroo mother care

Outcomes

Primary Outcomes

Change in work of breathing

Time Frame: 2 hours

Work of breathing will be measured before, during, and after KMC. Comparisons will be made.

Secondary Outcomes

  • Oxygen saturation(2 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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