The Effect of Phototherapy Treatment on Oxygen Saturation Measurement in Newborns

NCT04494217 | Completed

• 1 other identifier: 18815
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperbilirubinemia, Neonatal Indirect

Keywords

pulse oximeter, phototherapy, newborn

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related 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.

  PMID: 15686263 BACKGROUND

• 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.

  PMID: 2294914 BACKGROUND

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor in Neonatology

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: September 1, 2020
• Primary Completion: February 25, 2021
• Study Completion: August 25, 2021
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)