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Completed

NCT Number: NCT03529994

Work of Breathing and Oxygen Saturation in Infants Receiving High Flow Nasal Cannula (HFNC)

The purpose of this study is to compare work of breathing on different levels of high flow respiratory support on infants born between 27 and 37 weeks gestation.

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Key information

Conditions

High Flow Nasal Cannula

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Care Health Services, Inc.

Newark, Delaware, 19718, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Infants between 27 and 37 weeks corrected gestational age
  • >4 days PNA
  • Stable (i.e. not meeting exclusion criteria) and receiving non-invasive respiratory support (HFNC) for ≥ 12 hours
  • Requiring ≤ 40% supplemental FiO2 as determined by the clinical care team for clinical care purposes independent of this study

Exclusion criteria

  • Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of WOB measurements

Treatment and study plan

Enrollment

Other

All infants enrolled will have work of breathing assessed.

Primary outcomes

  1. Work of breathing indices

    Time frame: 2 hours

    Altering HFNC flow rates and its effect on work of breathing indices in preterm infants with respiratory insufficiency.

Secondary outcomes

  1. Intermittent hypoxia

    Time frame: 2 hours

    Altering HFNC flow rates and its effect on intermittent hypoxia in preterm infants with respiratory insufficiency.

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

  • Alfred I. duPont Hospital for Children

Registry information

Official study title

Work of Breathing and Oxygen Saturation Stability in Infants With Respiratory Insufficiency While Receiving Various Flow Rates of High Flow Nasal Cannula

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 21, 2018
Registry last updated
Aug 28, 2019

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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