Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice

NACompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

March 1, 2016

Primary Completion Date

October 2, 2017

Study Completion Date

October 5, 2017

Conditions
PhototherapyJaundice, Neonatal
Interventions
DEVICE

Sleeping bag phototherapy

This device has a LED light emitter that incorporates one fiber optic mesh and is protected by a vinyl cover and a disposable liner for patient comfort and hygiene. The phototherapy sleeping bag is conceived with the aim of increasing the surface of phototherapy by means of a double exposure: ventral and dorsal, which allows the insertion of two phototherapy devices of 20x30 centimeters. The ventral and dorsal caps incorporate mesh optical fibers that are connected to the light emitter, in which the phototherapy time can be programmed. The fiber optic meshes are protected by a vinyl cover and a disposable lining for patient comfort and hygiene.

DEVICE

Conventional phototherapy

This is a phototherapy device with six fluorescent tubes, four white and two blue, with adjustment of inclination and height incorporated. The device has a minimum height of 106 cm and a maximum of 152 cm, a depth of 64 cm and a width of 72 cm. The manufacturer recommends not using the lamp at distances of less than 50 cm because, although the heat radiation is minimal, this can influence distances less than 50 cm when the child is also exposed to infrared thermal radiation, typical of the servo cribs It is recommended to control temperature and eye protection due to the risk of ophthalmic injury from light, since the intensity of the light is concentrated in a single point.

Trial Locations (1)

110231

Hospital Universitario San Ignacio, Bogotá

All Listed Sponsors
collaborator

Hospital Universitario San Ignacio

OTHER

collaborator

Pontificia Universidad Javeriana

OTHER

lead

Nathalie Charpak

OTHER

NCT03570775 - Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice | Biotech Hunter | Biotech Hunter