NCT00179972

Brief Summary

The purpose of this study is to evaluate sensor longevity and skin integrity with two different models of neonatal pulse oximetry sensors currently used for monitoring oxygen levels in small infants.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

First QC Date

September 14, 2005

Last Update Submit

July 29, 2015

Conditions

Premature Birth

Keywords

Pulse oximetryPulse oximetry sensorsSkin IntegrityPrematurityNeonatal Intensive Care UnitInfant, premature

Interventions

Adhesive and non-adhesive oximetry sensorsDEVICE

A sample of 32 premature infants will be recruited to participate in this study in which an adhesive sensor and a nonadhesive sensor are compared. Both sensors will be simultaneously tested in each subject, for a period of 14 days, with one sensor on the right foot and the other sensor on the left foot. Data will be collected on sensor longevity, skin integrity at the sensor site, reason for sensor replacement and ease of use rating by the clinician. Data will be summarized using descriptive statistics.

Eligibility Criteria

AgeUp to 2 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

NICU of Ann \& RObert H. Lurie Children's Hospital of CHicago

You may qualify if:

  • Gestational age \< 34 weeks
  • Weight \< 3.0 kg
  • Postnatal age \< 2 weeks
  • Anticipated pulse oximetry monitoring for at least 14 days

You may not qualify if:

  • Presence of any skin irritation or breakdown on either foot
  • Foot impediments which would preclude proper placement of the test sensors
  • Known allergies to adhesive materials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Barbara A Fleming, RNC, MS

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

September 1, 2005

Study Completion

May 1, 2010

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

US(1)