Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice
Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal 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 sleeping bag), comparing it with conventional hospital phototherapy.
 Methods: randomized controlled clinical trial with newborns more than 2000 g of birth weight
 hospitalized 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 58 patients was calculated, 29 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. Bilirubin levels were taken at the start of
 phototherapy. Controls were at the beginning, every 8 hours and every 12 hours at the time of
 bilirubin stabilization in the case of hemolysis, or every 24 hours depending on risk
 factors. Axillary temperature was measured at the beginning of phototherapy, at 30 min, 60
 min, 120 min and every 24 hours during intervention. Physical examination and daily water
 balance 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 (a sleeping bag ), comparing
 it with conventional phototherapy for hospitalized patients. Methods: randomized controlled
 clinical trial with newborns more than 2000 g of birth weight that required phototherapy
 according to the guidelines of the American Academy of Pediatrics, admitted to the "Hospital
 Universitario San Ignacio Neonata Care Unit (NCU)" . The Protocol was evaluated and accepted
 by the 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 58 patients was calculated, 29 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 at the beginning, every 8 hours and every 12 hours at
 the time of bilirubin stabilization in the case of hemolysis, or every 24 hours depending on
 risk factors. Axillary temperature was measured at the beginning and during phototherapy.
 Physical examination and daily water balance were performed. Parents and health personnel
 answered a survey on comfort and perceptions with the use of the devices at the end of the
 intervention. Analysis: Comparison of means was made for decrease of bilirubin levels and
 body temperatures and chi-square for incidence of side effects and results of the survey.
Inclusion Criteria:

 -  Hyperbilirubinemia requiring phototherapy according to the guidelines of the American
 Academy of Pediatrics and management recommendations for preterm infants under 35
 weeks, adopted by the newborn unit of San Ignacio University Hospital.

 -  Birth weight more than 2000 grams.

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

 Exclusion Criteria:

 -  Diagnosis of pemphigus, scalded skin or burns that make phototherapy difficult.

 -  Patient who requires transfer for management in another institution by their health
 insurer.