Clinical Trials Logo
  1. Home
  2. Prematurity
  3. NCT01057472
  4. Details
NCT01057472 Clinical Trial

Repeatability and Feasibility of Infant Spirometry

Prematurity Clinical Trial

Official title:
Repeatability and Feasibility of Infant Spirometry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01057472
Other study ID # REK Vest 2009/1771
Secondary ID
Status Completed
Phase N/A
First received January 26, 2010
Last updated January 24, 2012
Start date January 2010
Est. completion date December 2011

Study information
Verified date January 2012
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 3 Months
Eligibility Inclusion Criteria:

- Being a Term born and preterm born babies

Exclusion Criteria:

- Being in an unstable clinical condition

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Pediatric Department, NICU Bergen

Sponsors (1)
Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Before and after a meal No
Secondary Feasibility of the measurements in the NICU 1 year No
See also
  Status Clinical Trial Phase
Recruiting NCT03670732 - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure N/A
Completed NCT05322161 - Yoga in the NICU for Parents Study N/A
Recruiting NCT04542096 - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting NCT04911452 - Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants N/A
Recruiting NCT02901652 - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome N/A
Completed NCT02148965 - Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial N/A
Completed NCT02273843 - A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis Phase 1
Terminated NCT02032511 - Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP) N/A
Completed NCT01721629 - Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants N/A
Terminated NCT01819532 - Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks N/A
Completed NCT00951860 - Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort N/A
Completed NCT01478711 - Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants N/A
Completed NCT01523769 - Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants N/A
Completed NCT00749008 - Study of Generalized Movements for Early Prediction of Cerebral Palsy N/A
Completed NCT00787124 - Transfusions and Nitric Oxide Level in Preterm Infants
Completed NCT00527956 - Facilitation and Barriers to Breastfeeding in the NICU N/A
Terminated NCT00486395 - Will CPAP Reduce Length Of Respiratory Support In Premature Infants? Phase 3
Terminated NCT01208493 - Dietary Protein in the Very-low-birth-weight Infant N/A
Completed NCT03372590 - NEO Rehab for Infants at Risk of Cerebral Palsy N/A
Completed NCT00033917 - Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial Phase 3

External Links