The Effect of Phototherapy Treatment on Oxygen Saturation Measurement in Newborns

The Influence of Phototherapy Lights on the Measurement of Oxygen Saturation With Pulse Oximeter in Newborns.

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.

Study Overview

• Status: Completed
• Conditions: Hyperbilirubinemia, Neonatal Indirect

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All newborn babies who are receiving phototherapy for indirect hyperbilirubinemia in the NICU of the Hacettepe University will be included in the study following the obtaining of informed consent by their parents/guardian.

The oxygen saturation of all babies receiving inpatient treatment in the NICU is routinely monitored with a pulse oximeter. In this study, the oxygen saturation of the newborns receiving phototherapy will be recorded.

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Oxygen Saturation Before and During Covering Oximeter Probe	The two data points (percent oxygen saturation before and during covering of oximeter probe) for each patient will be compared.	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.

Collaborators and Investigators

• Sponsor: Hacettepe University

Publications and helpful links

General Publications

• Vreman HJ, Wong RJ, Stevenson DK. Phototherapy: current methods and future directions. Semin Perinatol. 2004 Oct;28(5):326-33. doi: 10.1053/j.semperi.2004.09.003.
• Zubrow AB, Henderson GW, Imaizumi SO, Pleasure JR. Pulse oximetry in sick premature infants and the effects of phototherapy and radiant warmers on the oxygen saturation readout. Am J Perinatol. 1990 Jan;7(1):75-8. doi: 10.1055/s-2007-999451.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): February 25, 2021
• Study Completion (Actual): August 25, 2021

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: pulse oximeter, phototherapy, newborn
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: 18815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No