Clinical trial NCT03569254: Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice
Official title: Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Neonatal Jaundice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaundice, Neonatal
Phototherapy
Keywords: infant, newborn
devices
treatment
hyperbilirubinemia
Lead sponsor: Kangaroo Foundation
Sponsor class: OTHER
Collaborators: name: Hospital Universitario San Ignacio
First posted: 2018-06-26
Enrollment: 64
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment randomized controlled clinical trial with preterm or low birth weight infants who have low risk hyperbilirubinemia requiring phototherapy
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 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.

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 (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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bilirubin change rate in mg/dl/h
timeFrame: through study completion, an average of 6 hours
Secondary outcomes:
measure: Patient temperature during phototherapy
timeFrame: through study completion, an average of 6 hours
measure: Incidence of skin lesions related to phototherapy
timeFrame: through study completion, an average of 6 hours
measure: Incidence of dehydration related to phototherapy
timeFrame: through study completion, an average of 6 hours
measure: Incidence of diarrhea related to phototherapy
timeFrame: through study completion, an average of 6 hours
measure: Incidence of other side effects related to phototherapy
timeFrame: through study completion, an average of 6 hours
measure: Perceptions of parents with the use of devices
timeFrame: At study completion, an average of 6 hours.
measure: Perceptions of the health team with the use of the devices
timeFrame: At study completion, an average of 6 hours.
measure: Hospitalization for hyperbilirubinemia
timeFrame: Between beginning of treatment and 72 hours after
measure: Mortality
timeFrame: Between beginning of treatment and 72 hours after
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Hospital Universitario San Ignacio
Study officials:
affiliation: Kangaroo Foundation Director
name: Nathalie Charpak, Dr.
role: STUDY_DIRECTOR
References: