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OpenTrials
Completed

NCT Number: NCT03683316

Work of Breathing and Kangaroo Mother Care

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.

Completed

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Key information

Conditions

Premature Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Oxygen Saturation Pregnancy Complications Premature Birth Urogenital Diseases Work of Breathing

Age range

4 day–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Care Health Services, Inc

Newark, Delaware, 19718, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in work of breathing

    Time frame: 2 hours

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

Secondary outcomes

  1. Oxygen saturation

    Time frame: 2 hours

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

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2018
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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