Work of Breathing and Kangaroo Mother Care

NCT03683316 | Completed

• 1 other identifier: DDD603995
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Infant; Work of Breathing; Oxygen Saturation

Outcome Measures

Primary Outcomes (1)

• Change in work of breathing

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

  2 hours

Secondary Outcomes (1)

• Oxygen saturation

  2 hours

Study Arms (1)

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.

Eligibility Criteria

• Age: 4 Days - 6 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health Services, Inc

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Kelley Kovatis, MD

  Christiana Care Health Services

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: September 25, 2018
• Study Start: November 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

US (1)