Currently submitted to: JMIR Research Protocols
Date Submitted: Oct 13, 2020
Open Peer Review Period: Oct 6, 2020 - Dec 1, 2020
(currently open for review)
Phototherapy using a Light Emitting Fabrics device (Bubolight® device) in the treatment of new-born jaundice: Protocol for an interventional efficacy and safety study.
Neonatal jaundice is a very common condition occurring in 60–80% of all healthy term and late preterm neonates. In the newborn and especially in premature infants, the liver, which is still immature, is unable to eliminate the full amount of bilirubin. In the majority of cases, neonatal jaundice resolves spontaneously and causes no harm; however, in some babies, signiﬁcant hyperbilirubinemia can develop. Bilirubin then accumulates in the blood and when too high, it can then lead to a serious neurological disease: kernicterus jaundice. Phototherapy is an effective therapy for jaundice and 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 generate no or little heat and provide a wavelength and light intensity optimal (420-490nm and ≥ 30µw / cm²/nm)
The aim of the study is to investigate the feasibility, safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy, BUBOLight®, to which luminous textile have been incorporated in a sleeping bag. BUBOLight® emits homogeneous and stable light with a wavelength of 445 nm, for an irradiance of 3.5 mW/cm². It is easy to use and allows to carry out the phototherapy in the arms of the parents, thus preserving the parent–infant bonding. The primary end point of the study is to evaluate the safety of the BUBOLight® phototherapy device as an alternative to conventional hospital phototherapy under the usual conditions for the management of newborns jaundice. Secondary end points are the incidence of side effects (diarrhea, dehydration, skin lesions, temperature) related to phototherapy, evolution of blood bilirubin rate, perceptions of the parents and health team with the use of the device and the impact of the device on parent-child interactions and child comfort.
The trial is an interventional, exploratory, simple group, non-randomized and single center (Lille Hospital) study. Ten to fifteen newborns and their parents will be included to obtain evaluable data from 10 parent-newborn pairs. Newborns more than 2500g of birth weight and born at greater than or equal to 37 weeks of gestation that required phototherapy according to the guidelines of the National Institute For Health and Clinical Excellence will receive one session of 4 hours of illumination. Bilirubin seric and transcutaneous levels were taken at the start and 2 hours after the end of phototherapy. Axillary temperature, heart rate and oxygen saturation will be measured at the beginning and during phototherapy. Number of subjects is therefore not calculated on the basis of statistical assumptions. The objective is to obtain a minimum proportion of 90% of the newborns included (i.e. 9 out of 10) who have been able to undergo 4-hours phototherapy treatment without unacceptable and unexpected toxicities. We will calculate the mean, median, quartiles, minimum and maximum of the quantitative parameters and the frequency of the qualitative parameters. The rate of patients with no unacceptable and unexpected toxicities (primary endpoint) will be calculated.
First patient is expected to be included at the end of 2020 and clinical investigations are planned until June 2021. The final results of this study are expected to be available at the end of 2021
This trial aims to evaluate the safety and feasibility of a new phototherapy device based on light emitting fabrics for the treatment of newborn jaundice. The objective of this new system if, it is effective, to improve the humanization of newborn care avoiding the mother-and-child separation. Clinical Trial: ClinicalTrials.gov NCT04365998; https://clinicaltrials.gov/ct2/show/NCT04365998
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