NCT02878993

Brief Summary

This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

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

August 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 2, 2020

Status Verified

March 1, 2018

Enrollment Period

1.7 years

First QC Date

August 22, 2016

Last Update Submit

October 28, 2020

Conditions

Infant, Newborn, Disease

Outcome Measures

Primary Outcomes (2)

  • Magnitude of diaphragm EMG

    Magnitude of diaphragm EMG

    One hour

  • Ratio of diaphragm EMG to tidal volume

    Ratio of diaphragm EMG to tidal volume

    One hour

Secondary Outcomes (1)

  • Extubation success

    48 hours

Study Arms (1)

Intubated infants

Recording of diaphragm EMG

Device: Recording of diaphragm EMG

Interventions

Recording of diaphragm EMGDEVICE

Recording of diaphragm EMG prior to extubation using surface diaphragm electromyography

Intubated infants

Eligibility Criteria

Age0 Days - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants mechanically ventilated on NICU without major congenital abnormalities

You may qualify if:

  • intubated and mechanically ventilated on NICU

You may not qualify if:

  • major congenital abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, SE59RS, United Kingdom

Location

Related Publications (1)

  • Hunt KA, Hunt I, Ali K, Dassios T, Greenough A. Prediction of extubation success using the diaphragmatic electromyograph results in ventilated neonates. J Perinat Med. 2020 Jul 28;48(6):609-614. doi: 10.1515/jpm-2020-0129.

    PMID: 32598319BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anne Greenough

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

August 1, 2016

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

November 2, 2020

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)