NCT02571231

Brief Summary

The trial is a pilot study performed in the NICU's at Oslo University Hospital and Haukeland University Hospital preparing a multi-center randomized, controlled unblinded cross-over study, comparing high frequency ventilation (HFV) with and without volume guarantee (VG).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

September 28, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 8, 2015

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

September 28, 2015

Last Update Submit

October 7, 2015

Conditions

RdsPulmonary HypertensionMeconium Aspiration Syndrome

Outcome Measures

Primary Outcomes (3)

  • stability of High Frequency Tidal volumes

    HFVVt are measured by ventilator.

    during study, ie. 48 hours.

  • Stability of CO2 measurements

    Measured CO2 values will be measured as usual

    during study, ie. 48 hours.

  • frequency of needed manual adjustments on the ventilator

    Adjustments made on ventilator will be automatically sampled by the ventilator

    during study, ie 48 hours

Study Arms (2)

HFV+vg

EXPERIMENTAL

volume guarantee given

Device: HFV + and - VG

HFV-VG

EXPERIMENTAL

Volume guarantee not given

Device: HFV + and - VG

Interventions

HFV + and - VGDEVICE

High frequency ventilation with and without volume guarantuee

HFV+vgHFV-VG

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all neonates in need of high frequency ventilator

You may not qualify if:

  • neonates expected to need high frequency ventilator less than 48 hours because of planned surgery etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Lung InjuryHypertension, PulmonaryMeconium Aspiration Syndrome

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesRespiration DisordersFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Bjorn e Ogland, md dr philos

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bjorn e Ogland, md, Dr Philos

CONTACT

+47 94979001bjooeg@ous-hf.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

October 8, 2015

Study Start

November 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 8, 2015

Record last verified: 2015-09