Treatment Trials

5 Clinical Trials for Various Conditions

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COMPLETED
Clinical Performance Evaluation of Pediatric and Neonatal Low Saturation Oximetry Sensors
Description

The general purpose of this study is to evaluate the feasibility, accuracy and performance of the Nellcor/Covidian 600-x and the Masimo rainbow technologypediatric and neonatal oximetry sensors over clinically relevant ranges of arterial saturations between 60-100%. The study objectives are as follows: 1. To evaluate the accuracy of a neonatal sensor in the saturation range of 70-80% in the following weight category: 0-5kg. 2. To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand) sensors in the saturation range of 60-80% in the following weight categories: 0-5kg; and, 5-40kg. 3. To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand) sensors in the saturation range of 80-100% in the following weight ranges: 0-5kg; and, 5-40kg.

COMPLETED
N600X Low Saturation Accuracy Validation
Description

To compare pulse oximetry saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.

Conditions
COMPLETED
SpO2 Accuracy Low Saturation Validation of the OxySoftN Sensor
Description

To compare prototype pulse oximeter saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.

COMPLETED
Delivery Room CPAP in Extremely Low Birth Weight Infants
Description

This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants \<28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).

COMPLETED
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
Description

This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.