Clinical trial NCT03570775: Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice
Official title: Effectiveness, Safety and Perceptions With the Use of One Phototherapy LED Device: a Sleeping Bag for Hospital Treatment of Neonatal Jaundice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phototherapy
Jaundice, Neonatal
Keywords: hyperbilirubinemia
treatment
devices
newborn
phototherapy
Lead sponsor: Kangaroo Foundation
Sponsor class: OTHER
Collaborators: name: Hospital Universitario San Ignacio
name: Pontificia Universidad Javeriana
First posted: 2018-06-27
Enrollment: 58
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial with newborns over 2000 grams of birth weight and diagnosis of indirect hyperbilirubinemia, requiring phototherapy. Patients were randomized to phototherapy with the LED sleeping bag or conventional phototherapy with blue light panels.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bilirubin reduction rate in mg/dl/h
timeFrame: through study completion, an average of 5 days
Secondary outcomes:
measure: Patient temperature during phototherapy
timeFrame: through study completion, an average of 5 days
measure: Incidence of skin lesions related to phototherapy
timeFrame: through study completion, an average of 5 days
measure: Incidence of dehydration related to phototherapy
timeFrame: through study completion, an average of 5 days
measure: Incidence of diarrhea related to phototherapy
timeFrame: through study completion, an average of 5 days
measure: Incidence of other side effects related to phototherapy
timeFrame: through study completion, an average of 5 days
measure: Perceptions of parents with the use of devices (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)
timeFrame: at study completion, an average of 5 days
measure: Perceptions of the health team with the use of the devices (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)
timeFrame: at study completion, an average of 5 days
measure: Incidence of mortality
timeFrame: through study completion, an average of 5 days
measure: Incidence of exchange transfusion
timeFrame: through study completion, an average of 5 days
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Hospital Universitario San Ignacio
Study officials:
affiliation: Hospital Universitario San Ignacio
name: Margarita Andrade, Dr.
role: STUDY_CHAIR
affiliation: Kangaroo Foundation
name: Nathalie Charpak, Dr.
role: STUDY_DIRECTOR
References: