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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03683316
Other study ID # DDD603995
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date September 1, 2020

Study information

Verified date October 2020
Source Christiana Care Health Services
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date September 1, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers
Gender All
Age group N/A to 6 Months
Eligibility Inclusion Criteria:

- Very low birth weight infants (those less than 1500g at birth)

- 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 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

Study Design


Locations

Country Name City State
United States Christiana Care Health Services, Inc Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in work of breathing Work of breathing will be measured before, during, and after KMC. Comparisons will be made. 2 hours
Secondary Oxygen saturation Oxygen saturations will be measured before, during, and after KMC. Comparisons will be made. 2 hours
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