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Home phototherapy for hyperbilirubinemia in term neonates-an unblinded multicentre randomized controlled trial.

ABSTRACT: The aim of this study was to assess whether home phototherapy was feasible and safe in a cohort of otherwise healthy term-born neonates who fulfilled the criteria for in-hospital phototherapy. This was a randomized controlled trial in which term newborns with a total serum bilirubin of 18-24 mg/dL (300-400 μmol) were randomized to either home phototherapy or conventional in-hospital phototherapy. The primary outcome measurements were safety and efficacy, length of stay and the number of failed treatments. The secondary outcomes were the number of blood samples and weight gain during treatment. One hundred forty-seven patients were recruited, 69 patients randomized to conventional phototherapy and 78 to home phototherapy. The results showed that no patients needed blood exchange and only 4% of the patients allocated to home phototherapy were admitted to the hospital. The duration of phototherapy, length of stay, amount of blood tests and weight change showed no statically significant differences.Conclusion: Home phototherapy could be a safe alternative to inpatient phototherapy for otherwise healthy newborns with hyperbilirubinemia if daily checkups and 24/7 telephone support can be provided. The parents should be informed to contact the hospital immediately if they fail to perform the treatment at home.Trial registration: Clinicaltrials.gov NCT03536078 What is Known: • Phototherapy in the hospital is a safe and effective treatment without major side effects. • Fibre optic equipment has made the choice of home phototherapy possible. What is New: • This is the first randomized controlled trial comparing home phototherapy with hospital phototherapy. • Results indicate that home phototherapy could be considered as a safe and feasible alternative when performed according to instructions given, to hospital treatment for otherwise healthy term newborns.

SUBMITTER: Pettersson M

PROVIDER: S-EPMC8032579 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo determine whether ultraviolet B phototherapy at home is equally safe and equally effective as ultraviolet B phototherapy in an outpatient setting for patients with psoriasis.DesignPragmatic multicentre single blind randomised clinical trial (PLUTO study).SettingDermatology departments of 14 hospitals in the Netherlands.Participants196 patients with psoriasis who were clinically eligible for narrowband (TL-01) ultraviolet B phototherapy. The first 105 consecutive patients were also followed for one year after therapy.InterventionUltraviolet B phototherapy at home using a TL-01 home phototherapy unit compared with standard narrowband ultraviolet B phototherapy in an outpatient setting. Both therapies were done in a setting reflecting routine daily practice in the Netherlands.Main outcome measuresThe main outcome measure was effectiveness as measured by the proportion of patients with a 50% or more reduction of the baseline psoriasis area and severity index (PASI) or self administered psoriasis area and severity index (SAPASI), called the PASI 50 and SAPASI 50 (relevant treatment effect). Another outcome of effectiveness was the percentage reduction in median scores on the PASI as well as SAPASI. Also the proportions of patients reaching the PASI 75 and SAPASI 75 (successful treatment effect), and the PASI 90 and SAPASI 90 (almost complete clearance) were calculated. Other secondary outcomes were quality of life (SF-36, psoriasis disability index), burden of treatment (questionnaire), patients' preferences and satisfaction (questionnaire), and dosimetry and short term side effects (diary).Results82% of the patients treated at home compared with 79% of the patients treated in an outpatient setting reached the SAPASI 50 (difference 2.8%, 95% confidence interval -8.6% to 14.2%), and 70% compared with 73% reached the PASI 50 (-2.3%, -15.7% to 11.1%). For patients treated at home the median SAPASI score decreased 82% (from 6.7 to 1.2) and the median PASI score decreased 74% (from 8.4 to 2.2), compared with 79% (from 7.0 to 1.4) and 70% (from 7.0 to 2.1) for patients treated in an outpatient setting. Treatment effect as defined by the mean decline in PASI and SAPASI scores was significant (P<0.001) and similar across groups (P>0.3). Total cumulative doses of ultraviolet B light were similar (51.5 v 46.1 J/cm(2), difference 5.4, 95% confidence interval -5.2 to 16.0), and the occurrence of short term side effects did not differ. The burden of undergoing ultraviolet B phototherapy was significantly lower for patients treated at home (differences 1.23 to 3.01, all P</=0.001). Quality of life increased equally regardless of treatment, but patients treated at home more often rated their experience with the therapy as "excellent" (42%, 38/90) compared with patients treated in the outpatient department (23%, 20/88; P=0.001).ConclusionUltraviolet B phototherapy administered at home is equally safe and equally effective, both clinically and for quality of life, as ultraviolet B phototherapy administered in an outpatient setting. Furthermore, ultraviolet B phototherapy at home resulted in a lower burden of treatment and led to greater patients' satisfaction. Trial registration Current Controlled Trials ISRCTN83025173 and Clinicaltrials.gov NCT00150930.

Project description:Neonatal hyperbilirubinemia (jaundice) is common in infants, with extremely preterm infants (EPT, <28 weeks gestational age) being at high risk for bilirubin-induced neurotoxicity, resulting in neurodevelopmental impairment. Hyperbilirubinemia is treated using phototherapy to lower unconjugated bilirubin levels. However, the benefits and risks of phototherapy in EPTs have not been well studied, and bilirubin at low levels may be protective as an antioxidant. Phototherapy is associated with markers of oxidative stress in the plasma, but the effects of phototherapy on the hippocampus (HPC) are not known. Bilirubin and insults associated with EPTs impair hippocampal development, a brain structure critical for cognitive function, but their underlying mechanisms remain unknown. The effects of hyperbilirubinemia and phototherapy on the HPC were studied using a Gunn rat model. Jaundiced (jj) and non-jaundiced (Nj) pups were subjected to phototherapy from postnatal day 4 (P4) through P6. The HPC was harvested and processed for RNA sequencing. Serum bilirubin levels were elevated in jj compared to Nj control rats. Phototherapy significantly lowered serum bilirubin levels in jj rats. Compared to Nj rats, 1294 genes were differentially expressed in the jj hippocampal transcriptome and mapped onto the nervous system development, inflammation, and ferroptosis signaling pathways. Phototherapy induces 3297 differentially-expressed genes (DEGs) in rat hippocampal transcriptome compared to untreated rats. These DEGs were annotated to pathways regulating synaptogenesis, long-term potentiation, and neurogenesis. Both hyperbilirubinemia and phototherapy altered expression of 407 genes, which mapped onto hippocampal plasticity functions, including neuritogenesis and long-term potentiation. Our study demonstrates a model for investigating molecular effects of hyperbilirubemia and phototherapy in an EPT-equivalent Gunn rat pup. Our data revealed the effects of hyperbilirubinemia and phototherapy on signaling pathways critical for hippocampal development and plasticity.

Project description:There is an unmet need for phototherapy treatment in low- and middle-income countries (LMICs) to prevent disability and death of newborns with neonatal hyperbilirubinemia. Home phototherapy deployed by community health workers (CHWs) in LMICs may help increase access to essential newborn postnatal care in a more acceptable way for families and lead to an increase in indicated treatment rates for newborns with hyperbilirubinemia. We aimed to investigate the operational feasibility and acceptability of a CHW-led home phototherapy intervention in a rural sub-district of Bangladesh for families and CHWs where home delivery was common and a treatment facility for neonatal hyperbilirubinemia was often more than two hours from households. We enrolled 23 newborns who were ≥ 2 kg in weight and ≥ 35 weeks gestational age, without clinical danger signs, and met the American Academy of Pediatric treatment criteria for phototherapy for hyperbilirubinemia. We employed a mixed-method investigation to evaluate the feasibility and acceptability of home phototherapy through surveys, in-depth interviews and focus group discussions with CHWs, mothers, and grandparents. Mothers and family members found home phototherapy worked well, saved them money, and was convenient and easy to operate. CHWs found it feasible to deploy home phototherapy and identified hands-on training, mHealth job aids, a manageable workload, and prenatal education as facilitating factors for implementation. Feasibility and acceptability concerns were limited amongst parents and included: a lack of confidence in CHWs' skills, fear of putting newborn infants in a phototherapy device, and unreliable home power supply. CHW-led home phototherapy was acceptable to families and CHWs in rural Bangladesh. Further investigation should be done to determine the impact of home phototherapy on treatment rates and on preventing morbidity associated with neonatal hyperbilirubinemia. Clinical Trial (CT) registration ID: NCT03933423, full protocol can be accessed at https://doi.org/10.1186/s13102-024-00824-6 . Name of the trial registry: clinicaltrials.gov. Clinical Trial (CT) registration Date: 01/05/2019.

Project description:BACKGROUND:The efficacy of intraoperative corticosteroids to improve outcomes following congenital cardiac operations remains controversial. OBJECTIVES:The purpose of this study was to determine whether intraoperative methylprednisolone improves post-operative recovery in neonates undergoing cardiac surgery. METHODS:Neonates undergoing cardiac surgery with cardiopulmonary bypass at 2 centers were enrolled in a double-blind randomized controlled trial of methylprednisolone (30 mg/kg) or placebo after the induction of anesthesia. The primary outcome was a previously validated morbidity-mortality composite that included any of the following events following surgery before discharge: death, mechanical circulatory support, cardiac arrest, hepatic injury, renal injury, or rising lactate level (>5 mmol/l). RESULTS:Of the 190 subjects enrolled, 176 (n = 81 methylprednisolone, n = 95 placebo) were included in this analysis. A total of 27 (33%) subjects in the methylprednisolone group and 40 (42%) in the placebo group reached the primary study endpoint (odds ratio [OR]: 0.63; 95% confidence interval [CI]: 0.31 to 1.3; p = 0.21). Methylprednisolone was associated with reductions in vasoactive inotropic requirements and in the incidence of the composite endpoint in subjects undergoing palliative operations (OR: 0.38; 95% CI: 0.15 to 0.99; p = 0.048). There was a significant interaction between treatment effect and center. In this analysis, methylprednisolone was protective at 1 center, with an OR: 0.35 (95% CI: 0.15 to 0.84; p = 0.02), and not so at the other center, with OR: 5.13 (95% CI: 0.85 to 30.90; p = 0.07). CONCLUSIONS:Intraoperative methylprednisolone failed to show an overall significant benefit on the incidence of the composite primary study endpoint. There was, however, a benefit in patients undergoing palliative procedures and a significant interaction between treatment effect and center, suggesting that there may be center or patient characteristics that make prophylactic methylprednisolone beneficial.

Project description:ObjectiveTo assess the costs and cost effectiveness of phototherapy with ultraviolet B light provided at home compared with outpatient ultraviolet B phototherapy for psoriasis.DesignCost utility, cost effectiveness, and cost minimisation analyses performed alongside a pragmatic randomised clinical trial (the PLUTO study) at the end of phototherapy (mean 17.6 weeks) and at one year after the end of phototherapy (mean 68.4 weeks).SettingSecondary care, provided by a dermatologist in the Netherlands.Participants196 adults with psoriasis who were clinically eligible for narrowband (TL-01) ultraviolet B phototherapy were recruited from the dermatology departments of 14 hospitals and were followed until the end of phototherapy. From the end of phototherapy onwards, follow-up was continued for an unselected, consecutive group of 105 patients for one year after end of phototherapy.InterventionsUltraviolet B phototherapy provided at home (intervention) and conventional outpatient ultraviolet B phototherapy (control) in a setting reflecting routine practice in the Netherlands. Both treatments used narrowband ultraviolet B lamps (TL-01).Main outcome measuresTotal costs to society, quality adjusted life years (QALYs) as calculated using utilities measured by the EQ-5D questionnaire, and the number of days with a relevant treatment effect (>/=50% improvement of the baseline self administered psoriasis area and severity index (SAPASI)).ResultsHome phototherapy is at least as effective and safe as outpatient phototherapy, therefore allowing cost minimisation analyses (simply comparing costs). The average total costs by the end of phototherapy were euro800 for home treatment and euro752 for outpatient treatment, showing an incremental cost per patient of euro48 (95% CI euro-77 to euro174). The average total costs by one year after the end of phototherapy were euro1272 and euro1148 respectively (difference euro124, 95% CI euro-155 to euro403). Cost utility analyses revealed that patients experienced equal health benefits-that is, a gain of 0.296 versus 0.291 QALY (home v outpatient) by the end of phototherapy (difference 0.0052, -0.0244 to 0.0348) and 1.153 versus 1.126 QALY by one year after the end of phototherapy (difference 0.0267, -0.024 to 0.078). Incremental costs per QALY gained were euro9276 and euro4646 respectively, both amounts well below the normally accepted standard of euro20 000 per QALY. Cost effectiveness analyses indicated that the mean number of days with a relevant treatment effect was 42.4 versus 55.3 by the end of phototherapy (difference -12.9, -23.4 to -2.4). By one year after the end of phototherapy the number of days with a relevant treatment effect were 216.5 and 210.4 respectively (6.1, -41.1 to 53.2), yielding an incremental cost of euro20 per additional day with a relevant treatment effect.ConclusionsHome ultraviolet B phototherapy for psoriasis is not more expensive than phototherapy in an outpatient setting and proved to be cost effective. As both treatments are at least equally effective and patients express a preference for home treatment, the authors conclude that home phototherapy should be the primary treatment option for patients who are eligible for phototherapy with ultraviolet B light.Trial registrationCurrent Controlled Trials ISRCTN83025173 and Clinicaltrials.gov NCT00150930.

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Home phototherapy for hyperbilirubinemia in term neonates-an unblinded multicentre randomized controlled trial.

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