Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice
Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice
Objective: to evaluate the effectiveness, safety and level of satisfaction of parents and
 healthcare team with one innovative device for phototherapy to which a LED light mesh has
 been incorporated(a blanket), comparing it with the Ohmeda BiliBlanket Plus®. Methods:
 randomized controlled clinical trial with preterm or low birth weight infants requiring
 phototherapy. The study protocol was evaluated and accepted by the San Ignacio Hospital and
 "Pontificia Universidad Javeriana" research committee. Informed consent was requested from
 parents and the authors declared no conflict of interest. Sample size and allocation: using
 the STATA 12 program, a sample size of 64 patients was calculated(5% losses), 32 for each
 group, with significance level of 0.05, power of 80% and difference in bilirubin decreasing
 of at least 0,1 mg/dl/h with standard deviation of 0.14 mg/dl/h. A computer program
 randomized the allocation to the intervention and the concealment of the assignment was
 through sealed opaque envelopes. Seric bilirubin levels were taken at the start and at the
 end of phototherapy. Controls were done every 2 hours with the Bilicheck spectrophotometer
 device. Axillary temperature was measured at the beginning of phototherapy, at 30 min, 60
 min, and every 2 hours during intervention. Physical examination and recording of side
 effects related were performed. Parents and health personnel answered a survey on comfort and
 perceptions with the use of the devices at the end of phototherapy. Analysis: Comparison of
 means was made for the decrease of bilirubin levels and body temperatures and chi-square for
 incidence of side effects and results of the survey.
Background: Jaundice due to hyperbilirubinemia is the most common entity that requires
 medical management in neonates. About 50% of full-term newborns and 80% of premature infants
 develop jaundice. The effectiveness of phototherapy for neonatal jaundice depends on two
 factors: the spectrum of light emitted and the spectral irradiation of light. An ideal
 phototherapy device should have a broad light emission surface, in order to cover the maximum
 of the body surface in the horizontal plane, it should be durable, generate relatively little
 heat and provide a wavelength and light intensity (radiation) optimal (460-490nm and ≥ 30uw /
 cm2 / nm). The conventional phototherapy devices use fluorescent lamps that emit heat and
 require eye protectors, in addition to increasing water losses, which requires a permanent
 monitoring of vital functions and temperature. Its use imposes hospitalization and
 consequently mother-child separation, always traumatic. The most recent devices use light
 emitting diodes (LED light) as the light source. Objective: to evaluate the effectiveness,
 safety and level of satisfaction of parents and healthcare team with one innovative device
 for phototherapy to which a LED light mesh has been incorporated (one blanket), comparing it
 with the Ohmeda BiliBlanket Plus®, used at the Kangaroo Mother Care Program for intermittent
 ambulatory phototherapy. Methods: randomized controlled clinical trial with preterm or low
 birth weight infants that required phototherapy according to the guidelines of the American
 Academy of Pediatrics. The Protocol was evaluated and accepted by the "Hospital Universitario
 San Ignacio and Pontificia Universidad Javeriana research committee". Informed consent was
 requested from parents and the authors declared no conflict of interest. Sample size and
 allocation: using the STATA 12 program, a sample size of 64 patients was calculated, 32 for
 each group, with significance level of 0.05, power of 80% and difference in bilirubin
 decreasing of at least 0,1 mg/dl/h with standard deviation of 0.14 mg/dl/h and 5% of losses.
 A computer program randomized the allocation to the intervention and the concealment of the
 assignment was through sealed opaque envelopes. Seric bilirubin levels were taken at the
 start and at the end of phototherapy. Controls were done every 2 hours with bilicheck
 spectrophotometer device. Axillary temperature was measured at the beginning of phototherapy,
 at 30 min, 60 min, and every 2 hours during intervention. Physical examination, recording of
 side effects related, mortality and requirement of hospital treatment were performed. Parents
 and health personnel answered a survey on comfort and perceptions with the use of the devices
 at the end of phototherapy. Analysis: Comparison of means was made for the decrease of
 bilirubin levels and body temperatures and chi-square for incidence of side effects,
 hospitalization, mortality and results of the survey.
Inclusion Criteria:

 -  Low Risk Hyperbilirubinemia requiring phototherapy according to the guidelines of the
 American Academy of Pediatrics and recommendations for management of premature infants
 under 35 weeks, adopted by the Kangaroo Mother Care Ambulatory Program.

 -  Start of jaundice at a chronological age greater than 48 hours.

 -  Bilirubin level ≤18 mg / dL

 -  Knowledge of blood groups of mother and child.

 -  Parents are required to sign informed consent where they agree to participate in the
 study.

 Exclusion Criteria:

 -  Parents without availability to stay in the Kangaroo Mother Care Program for at least
 6 hours.

 -  Extensive skin lesions due to burns or sloughing at the physical examination prior to
 entering the study.