Premature BirthNCT00179972
Evaluation of Pulse Oximetry Sensors in Neonates
An observational study of Premature Birth, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- Adhesive and non-adhesive oximetry sensors
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 weeks
- All sexes
- No healthy volunteers
- Child
Study population: NICU of Ann \& RObert H. Lurie Children's Hospital of CHicago
Who may be able to join
- Gestational age < 34 weeks
- Weight < 3.0 kg
- Postnatal age < 2 weeks
- Anticipated pulse oximetry monitoring for at least 14 days
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
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.
Read the 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.
- Conditions
- Premature Birth
- Being tested
- Adhesive and non-adhesive oximetry sensors
- Keywords
- Pulse oximetry, Pulse oximetry sensors, Skin Integrity, Prematurity, Neonatal Intensive Care Unit, Infant, premature
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2005
- Study completionMay 2010
Why it stopped: Lack of resources and loss of personnel precluded study progress. No adverse events or unanticipated problems involving risks to subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Barbara A Fleming, RNC, MS, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179972
- Sponsor's protocol ID
- 2005-196N
- Status last verified
- Jul 2015
- First submitted
- 14 Sep 2005
- Last updated
- 31 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pulse Oximetry Sensors in Neonates
- ClinicalTrials.gov ID
- NCT00179972
- Acronym / sponsor ID
- 2005-196N
- Conditions
- Premature Birth
- Keywords
- Pulse oximetry, Pulse oximetry sensors, Skin Integrity, Prematurity, Neonatal Intensive Care Unit, Infant, premature
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of resources and loss of personnel precluded study progress. No adverse events or unanticipated problems involving risks to subjects.
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Sep 2005
- Study completion
- May 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- NICU of Ann \& RObert H. Lurie Children's Hospital of CHicago
Key inclusion criteria (4 listed)
- Gestational age < 34 weeks
- Weight < 3.0 kg
- Postnatal age < 2 weeks
- Anticipated pulse oximetry monitoring for at least 14 days
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adhesive and non-adhesive oximetry sensorsA 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. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Lack of resources and loss of personnel precluded study progress. No adverse events or unanticipated problems involving risks to subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara A Fleming, RNC, MS principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of resources and loss of personnel precluded study progress. No adverse events or unanticipated problems involving risks to subjects.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.