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Evaluation of Pulse Oximetry Sensors in Neonates
This study is currently recruiting participants.
Verified by Children's Memorial Hospital, September 2005
Sponsors and Collaborators: Children's Memorial Hospital
Nellcor Puritan Bennet
Information provided by: Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00179972
  Purpose

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.


Condition Intervention
Premature Birth
Device: Adhesive and non-adhesive oximetry sensors

U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Cross-Sectional, Defined Population, Prospective Study
Official Title: Evaluation of Pulse Oximetry Sensors in Neonates

Further study details as provided by Children's Memorial Hospital:

Estimated Enrollment: 32
Study Start Date: September 2005
Estimated Study Completion Date: May 2006
Detailed Description:

A common method for assessing the respiratory status of hospitalized children is the use of pulse oximetry. This noninvasive device typically is placed on a finger, foot/palm of a child. Red and infrared light is shined through the tissue under the sensor and the information is sent back to a monitor for calculation of oxygen saturation. Use of this noninvasive method provides continuous information on the oxygenation status of patients and has greatly reduced the number of arterial blood samples required for patient care.

While the advantages of noninvasive pulse oximetry are significant, there are a number of factors which can negatively impact the performance of the device. Patient movement and sensor adherence to the skin have been some of the challenges to optimal device performance. While much of the clinical research on pulse oximetry sensors over the years has evaluated device accuracy and reliability, limited data is available on sensor longevity under conditions typical of clinical use. A particular challenge with neonatal pulse oximetry monitoring is insuring proper sensor adherence within the warm, moist environment of incubators used in neonatal care. Furthermore, limited data are available on the impact of sensor adherence on skin integrity in premature infants who are at high risk for skin breakdown.

Objectives. The purpose of this study is to evaluate sensor longevity and impact on skin integrity in neonatal patients with two different models of pulse oximetry sensors.

Research Method. 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

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179972

Contacts
Contact: Barbara A Fleming, RNC, MS 773-868-8955 bfleming@childrensmemorial.org

Locations
United States, Illinois
Children's Memorial Hospital Recruiting
Chicago, Illinois, United States, 60614
Contact: Philip V Spina, CRA     773-755-6301     pspina@childrensmemorial.org    
Principal Investigator: Barbara A Fleming, RNC, MS            
Sponsors and Collaborators
Children's Memorial Hospital
Nellcor Puritan Bennet
Investigators
Principal Investigator: Barbara A Fleming, RNC, MS Children's Memorial Hospital
  More Information

Study ID Numbers: 2005-196N
Study First Received: September 14, 2005
Last Updated: January 23, 2006
ClinicalTrials.gov Identifier: NCT00179972  
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Memorial Hospital:
Pulse oximetry
Pulse oximetry sensors
Skin Integrity
Prematurity
Neonatal Intensive Care Unit
Infant, premature

Study placed in the following topic categories:
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

ClinicalTrials.gov processed this record on January 14, 2009