The Effect of Phototherapy Treatment on Oxygen Saturation Measurement in Newborns

Hyperbilirubinemia, Neonatal Indirect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494217
• Other study ID #: 18815
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: August 25, 2021

Study information

• Verified date: September 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Hyperbilirubinemia, Neonatal Indirect

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.