Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice

NACompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

March 1, 2016

Primary Completion Date

October 5, 2017

Study Completion Date

October 5, 2017

Conditions
Jaundice, NeonatalPhototherapy
Interventions
DEVICE

Neomedlight Phototherapy Blanket

The NeoMedLight® phototherapy blanket is an innovative new fiber-optic device based on LED light. Its light emitting surface area is 40.5x30 cm or 1200 cm2. The device size is 40.5 x30 cm. It incorporates fiber optic mesh and is protected by a vinyl cover and a disposable liner for patient comfort and hygiene. This device provides therapeutic light (404-515nm) to a wide extension of the body surface area. Its average irradiation footprint is 35uW / cm2 / nm ± 15%. The phototherapy was done intermittently in periods of 2 hours with 1 hour of rest for a total time of 6 hours in kangaroo position.

DEVICE

Ohmeda-Fiber Optic Phototherapy Blanket

This device is a high performance version of Ohmeda Medical's Biliblanket that uses a fiber optic cable to deliver light from a high-intensity lamp to a device composed of a fiber optic fabric. The device has a disposable liner and is left in direct contact with the patient. The patient is exposed to a light with a wavelength between 400 and 550 nanometers. The phototherapy system consists of a light emitting unit, a fiber optic cable four feet long (121.9 cm) and a lightweight mattress. It has two available sizes: 4.38 x 9.38 inches (11.12 x 23.83 cm) and 4.00 x 6.00 inches (10.16 x 15.2 cm).

Trial Locations (1)

110231

Hospital Universitario San Ignacio, Bogotá

All Listed Sponsors
collaborator

Hospital Universitario San Ignacio

OTHER

lead

Nathalie Charpak

OTHER

NCT03569254 - Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice | Biotech Hunter | Biotech Hunter