Work of Breathing and Kangaroo Mother Care

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

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 Overview

• Status: Completed
• Conditions: Premature Infant; Work of Breathing; Oxygen Saturation

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Services, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 days to 6 months (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Very low birth weight infants in the NICU who meet inclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in work of breathing	Work of breathing will be measured before, during, and after KMC. Comparisons will be made.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation	Oxygen saturations will be measured before, during, and after KMC. Comparisons will be made.	2 hours

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Investigators: Study Director: Kelley Kovatis, MD, Christiana Care Health Services

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): August 1, 2020
• Study Completion (ACTUAL): September 1, 2020

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (ACTUAL): September 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: DDD603995

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No