Work of Breathing and Kangaroo Mother Care

Premature Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683316
• Other study ID #: DDD603995
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Oxygen Saturation
• Premature Infant
• Respiratory Aspiration
• Work of Breathing

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