Repeatability and Feasibility of Infant Spirometry

NCT ID: NCT01057472

Last Updated: 2012-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-12-31

Brief Summary

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This is a study examining repeatability and feasibility of a new method for measurement of lung function in babies. A flexible vest is placed around the torso of the baby, and changes in tidal volume and flow is measured. The study will enable a better understanding of the usefulness of this equipment in a neonatal intensive care unit. The equipment is made by VOLUSENSE Norway AS, and marketed under the name FloRight. The equipment is owned by Volusense Norway AS during the study period.

Detailed Description

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Conditions

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Prematurity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Term born babies

Term born babies

No interventions assigned to this group

Preterm babies ready for discharge

Preterm babies ready for discharge

No interventions assigned to this group

Preterm stable babies 1500 grams

Preterm stable babies 1500 grams

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Being a Term born and preterm born babies

Exclusion Criteria

* Being in an unstable clinical condition
Minimum Eligible Age

4 Weeks

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Halvorsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

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Pediatric Department, NICU

Bergen, , Norway

Site Status

Countries

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Norway

Related Links

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Other Identifiers

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REK Vest 2009/1771

Identifier Type: -

Identifier Source: org_study_id

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