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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04494217
Enrollment
50
Registered
2020-07-31
Start date
2020-09-01
Completion date
2021-08-25
Last updated
2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperbilirubinemia, Neonatal Indirect

Keywords

pulse oximeter, phototherapy, newborn

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.

Interventions

None listed

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percent Oxygen Saturation Before and During Covering Oximeter ProbeThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026