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The Effect of Phototherapy Treatment on Oxygen Saturation Measurement in Newborns

H

Hacettepe University

Status

Completed

Conditions

Hyperbilirubinemia, Neonatal Indirect

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

Under 28 days old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

İrem İyigün, MD; H Tolga Çelik, MD, Ass Prof

Data sourced from clinicaltrials.gov

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