NCT03529994

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 28, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

May 8, 2018

Last Update Submit

August 27, 2019

Conditions

High Flow Nasal Cannula

Outcome Measures

Primary Outcomes (1)

  • Work of breathing indices

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

    2 hours

Secondary Outcomes (1)

  • Intermittent hypoxia

    2 hours

Study Arms (1)

Enrollment

Other: Enrollment

Interventions

EnrollmentOTHER

All infants enrolled will have work of breathing assessed.

Enrollment

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Convenience sample of infants on HFNC admitted to our NICU who meet inclusion criteria.

You may qualify if:

  • Infants between 27 and 37 weeks corrected gestational age
  • \>4 days PNA

You may not qualify if:

  • Requiring ≤ 40% supplemental FiO2 as determined by the clinical care team for clinical care purposes independent of this study
  • Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of WOB measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health Services, Inc.

Newark, Delaware, 19718, United States

Location

Study Officials

  • Kelley Kovatis, MD

    Christiana Care Health Services, Inc.

    PRINCIPAL INVESTIGATOR

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

May 21, 2018

Study Start

April 15, 2018

Primary Completion

July 31, 2019

Study Completion

August 1, 2019

Last Updated

August 28, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)