Hyperbilirubinemia, Neonatal IndirectNCT04494217
The Effect of Phototherapy Treatment on Oxygen Saturation Measurement in Newborns
An observational study of Hyperbilirubinemia, Neonatal Indirect, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Hyperbilirubinemia, Neonatal Indirect
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 25 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- newborn babies (0-28 days)
- to be treated in the Hacettepe University Children's Hospital Neonatal Intensive Care Unit
- receiving phototherapy treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperbilirubinemia, Neonatal Indirect
- Keywords
- pulse oximeter, phototherapy, newborn
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Sep 2020
- Primary completion25 Feb 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hyperbilirubinemia, Neonatal IndirectStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. Tolga Çelik, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494217
- Sponsor's protocol ID
- 18815
- Status last verified
- Sep 2023
- First submitted
- 28 Jul 2020
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15686263Zubrow 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.
PubMed 2294914
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Phototherapy Lights on the Measurement of Oxygen Saturation With Pulse Oximeter in Newborns.
- ClinicalTrials.gov ID
- NCT04494217
- Acronym / sponsor ID
- 18815
- Conditions
- Hyperbilirubinemia, Neonatal Indirect
- Keywords
- pulse oximeter, phototherapy, newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- newborn babies (0-28 days)
- to be treated in the Hacettepe University Children's Hospital Neonatal Intensive Care Unit
- receiving phototherapy treatment
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent Oxygen Saturation Before and During Covering Oximeter Probe
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.
The two data points (percent oxygen saturation before and during covering of oximeter probe) for each patient will be compared.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 15686263Vreman 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.
- Background: PubMed 2294914Zubrow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperbilirubinemia, Neonatal Indirect, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Oxygen Saturation Before and During Covering Oximeter Probe (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04494217, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.