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CompletedNCT03683316Updated Oct 5, 2020

Work of Breathing and Kangaroo Mother Care

An observational study in Premature Infant, Work of Breathing and Oxygen Saturation, sponsored by Christiana Care Health Services. Completed at 1 site in United States. Open to participants aged 4 Days to 6 Months. Per ClinicalTrials.gov, last updated 2020-10-05.

Sponsored by Christiana Care Health Services · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
29
Ages
4 Days to 6 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Premature Infant
  • Work of Breathing
  • Oxygen Saturation
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 214 are open to participants now.

This study's enrollment of 29 is below the median of 65 across 184 observational studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Days to 6 Months
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
29 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Change in work of breathing

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

    Time frame: 2 hours

Secondary outcomes

  1. Oxygen saturation

    Oxygen saturations will be measured before, during, and after KMC. Comparisons will be made.

    Time frame: 2 hours

07

Study locations

1 site
  • Christiana Care Health Services, Inc
    Newark, Delaware 19718, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03683316
Lead sponsor
Christiana Care Health Services
Responsible party
Sponsor
First posted
Sep 25, 2018
Start date
Nov 1, 2018
Primary completion
Aug 1, 2020
Completion
Sep 1, 2020
Last update
Oct 5, 2020

Study contacts

Kelley Kovatis, MD
study director · Christiana Care Health Services

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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