Skip to main content
OpenTrials
Completed

NCT Number: NCT01057472

Repeatability and Feasibility of Infant Spirometry

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

4 week–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Department, NICU

Bergen, 5021, Norway

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Being a Term born and preterm born babies

Exclusion criteria

  • Being in an unstable clinical condition

Treatment and study plan

Primary outcomes

  1. Repeatability of measurements performed by two different nurses before and after a meal in term babies (10), preterm babies before discharge (10) and preterm babies weighing approximately 1500 grams

    Time frame: Before and after a meal

Secondary outcomes

  1. Feasibility of the measurements in the NICU

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 27, 2010
Registry last updated
Jan 25, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.