An observational study in Hyperbilirubinemia, Neonatal Indirect, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Hacettepe University · Observational
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.
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.
93 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.
This study's enrollment of 50 is below the median of 303 across 32 observational studies indexed under Hyperbilirubinemia, Neonatal.
Browse Hyperbilirubinemia, Neonatal studies →Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Time frame: 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.
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hacettepe University