The Effect of Phototherapy Treatment on Oxygen Saturation Measurement in Newborns

Completed

• Conditions: Hyperbilirubinemia, Neonatal Indirect

• Registration Number: NCT04494217
• Lead Sponsor: Hacettepe University

Brief Summary

This will be a prospective clinical study conducted with the approval of the Clinical Research Ethics Committee.

The influence of phototherapy lights on the accuracy of pulse oximetry will be investigated.

Detailed Description

Each patient's oxygen saturation will be measured non-invasively via a nondisposable polyethylene neonatal probe taped to the infant's palm, toe, or dorsum of the foot. The probe will be connected to an Massimo Rad97 pulse oximeter that is standardized at the factory. It runs through an automatic systems check when turned on and needs no further calibration before being used. The oxygen saturation measurements will be considered valid when there will be a normal plethysmographic waveform, a fullscale signal strength bar, and a stable heart rate closely approximating an independent electrocardiographic (ECG) pulse rate. The pulse oximeter works by using the technology of plethsmography which allows the detection of an arterial pulse) with oximetry (which measures oxygen saturation at specific wavelengths). The pulse oximeter will be placed on each infant as already described. After a stable pulse oximeter reading was obtained, the value will be recorded ("before") and then the probe will be covered with a standard disposable diaper, shiny side up. When the reading stabilized, the value will be recorded ("during") and then the diaper will be removed.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-31
• Study Start: 2020-09-01
• Primary Completion: 2021-02-25
• Study Completion: 2021-08-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• newborn babies (0-28 days)
• to be treated in the Hacettepe University Children's Hospital Neonatal Intensive Care Unit
• receiving phototherapy treatment

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Exclusion Criteria

• Newborn babies with any diseases that affect oxygen saturation including congenital heart disease, chromosomal disease, inborn error of metabolism, anemia, circulatory disorder, hypovolemia or hydrops fetalis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent Oxygen Saturation Before and During Covering Oximeter Probe	The two data (''before'' and ''during'') will be recorded consecutively for each infant, when the reading stabilize. All measurements will be completed wiithin 6 months according to the study protocol calendar.	The two data points (percent oxygen saturation before and during covering of oximeter probe) for each patient will be compared.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey