Evaluation of therapeutic effect of oral Ursodeoxycholic Acid on indirect hyperbilirubinemia in term neonates undergoing phototherapy: A randomized controlled clinical trial
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SUBMITTER: Zarkesh M
PROVIDER: S-EPMC10715657 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Project description: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.
| S-EPMC8032579 | biostudies-literature
Project description:BackgroundNeonatal hyperbilirubinemia is observed in most newborns, and 5-15% of neonates require phototherapy. Phototherapy is effective but often prolongs hospitalization and has both short-term and potential long-term harms. The aim of this systematic review and meta-analysis was to evaluate the role of ursodeoxycholic acid (UDCA) combined with phototherapy in neonatal hyperbilirubinemia.MethodsA literature search was conducted on September 1, 2021; 590 studies were screened, and 17 full texts were assessed by two authors. We included randomized controlled trials with or without placebo intervention. Primary outcomes were changes in total bilirubin levels at 24 hours and phototherapy duration. We calculated mean differences with 95% confidence intervals (CI).ResultsSix studies with 880 neonates were included. Of these studies, only two used a placebo-controlled double-blinded design. The overall risk of bias was high in one and moderate in four of the included studies. The mean decrease in the total bilirubin level during the first 24 hours was 2.06 mg/dL (95% CI 0.82-3.30; six studies) greater in the UDCA treatment group. The phototherapy duration was 19.7 hours (95% CI 10.4-29.1; five studies) shorter in the UDCA treatment group.ConclusionsWe found low-quality evidence that UDCA as an adjuvant to phototherapy seems to decrease total bilirubin faster and shorten phototherapy duration compared to standard treatment. Further studies are needed to confirm the efficacy, acute and long-term outcomes, and safety before implementing UDCA as an adjuvant to phototherapy in neonatal hyperbilirubinemia.
| S-EPMC9376150 | biostudies-literature
Project description:BackgroundPhototherapy is a common treatment for neonatal hyperbilirubinemia, however it generates reactive oxygen species and induces apoptosis, potentially influencing blood cells. Assessing changes in hematological parameters is essential to minimize complications and enhance outcomes.ObjectiveThis study assessed hematological parameters changes and associated factors in neonates with hyperbilirubinemia undergoing phototherapy.MethodA cross-sectional study was conducted at the University of Gondar Comprehensive Specialized Hospital from May 29 to November 8, 2023. About 246 neonates were selected by convenient sampling. Blood samples were collected before and after phototherapy. Data were entered into Epi-data (4.6.0) and analyzed using SPSS (25.0). The normality of the data was checked by Kolmogorov-Smirnov tests. A paired t-test and Wilcoxon Sign Rank test were used to compare mean differences for normally distributed and skewed data, respectively. Pearson correlation and multiple linear regressions were used to measure the association. A significance level of p < 0.05 was used for statistical significance.ResultAmong neonates, 141 (57.3%) were males, and the median age was 2 days. Phototherapy treatment led to significant increases in WBC and lymphocyte count, 11.02 ± 2.21 to 11.35 ± 2.60, and 3.93 ± 1.19 to 4.16 ± 1.34, respectively. However, hemoglobin and platelet count significantly decreased from 15.05 ± 3.67 to 14.55 ± 2.62, and 243.23 ± 74.78 to 239.32 ± 73.29, respectively. Other blood cell parameters were unaffected. WBC and lymphocytes showed a positive association with preterm neonates and intensive phototherapy, while WBC count showed a negative association with total bilirubin. Hemoglobin counts are positively associated with total bilirubin but negatively associated with neonate age and treatment duration. Platelet count showed negative associations with low-birth-weight neonates, intensive phototherapy, and treatment duration. After treatment, normocytic normochromic cells increased, microcytic hypochromic decreased, and abnormal RBC shapes were reduced.ConclusionPhototherapy significantly affected key hematological parameters, notably WBC, lymphocytes, hemoglobin, and platelet count. Treating neonates with intensive phototherapy affects WBC and platelet counts while undergoing phototherapy for a longer duration affects hemoglobin and platelet counts. Therefore, routine monitoring of these parameters is crucial for neonates undergoing intensive or prolonged phototherapy.
| S-EPMC11829535 | biostudies-literature
Project description:This study aimed to establish the cost-effectiveness of home phototherapy versus hospital phototherapy treating hyperbilirubinemia in neonates more than 36 weeks. Based on clinical results from a randomised controlled trial showing that home phototherapy for hyperbilirubinemia in term neonates is as effective as hospital phototherapy, we performed a cost-minimisation analysis to identify the most cost-effective alternative. We included costs for health care resource use as well as costs for transportation in connection with re-visits. The cost per patient was €337 for home phototherapy compared with €1156 for the hospital alternative indicating average cost savings of €819 (95% confidence interval €613-1025) or 71% per patient. Transportation and outpatient costs were higher in the home treatment group and hospital care costs were higher in the hospital group. Sensitivity analysis shows that results are robust also when allowing for uncertainty. Home phototherapy for neonates more than 36 weeks costs less than in-hospital phototherapy while being equally effective, meaning that home phototherapy is a cost-effective alternative to hospital treatment for infants with neonatal hyperbilirubinemia.Trial registration NCT03536078 . Date of registration: 24/05/2018.
| S-EPMC10317991 | biostudies-literature
Project description:BackgroundNeonatal jaundice is a transitional phenomenon affecting three out of five full-term newborns globally. Ursodeoxycholic acid could be beneficial in neonatal jaundice needing phototherapy. METHODS: We searched PubMed, EBSCO, ProQuest, and Cochrane Library up to August 21st, 2021, for articles to be reviewed. Meta-analysis using random-effects model was performed.ResultsEight studies involving 1116 neonates were chosen in this review; however, only five studies were included for meta-analysis. Phototherapy duration was significantly lower in the interventional group with high heterogeneities. Subgroup analysis of the phototherapy duration based on the risk of bias resulted in a shorter duration (mean difference (MD) = -17.82; 95% CI = -20.17 to -15.47; p = < 0.001) with low heterogeneity in the treatment group. Secondary outcome focusing on mean total serum bilirubin showed a lower mean total serum bilirubin in 48 h post-treatment (MD = -0.43; 95% CI = -0.64 to -0.22; p = < 0.0001) with low heterogeneities in Asian countries."ConclusionsUrsodeoxycholic acid might be considered as a novel adjuvant therapy in neonatal indirect hyperbilirubinemia to shorten the phototherapy duration and lower the mean total serum bilirubin.
| S-EPMC9575272 | biostudies-literature
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.
2021-11-26 | GSE189509 | GEO
Project description:Newborns with hyperbilirubinemia have traditionally received phototherapy in hospital. Hospital stays for infants, however, may negatively affect parent-infant bonding and induce anxiety and feelings of powerlessness in mothers. This study examined parent's experiences of providing phototherapy to their neonates at home instead. A descriptive qualitative study based on 15 interviews (8 mothers and 7 fathers) with parents of 8 children who had been randomised to home phototherapy was conducted during spring 2018 in Örebro county, Sweden. Inductive content analysis was used. The overall experience of home phototherapy was positive, and five categories were identified describing their experiences: continuing life at home, adjusting to having a newborn, feeling secure, experiencing parenthood and accessing information. The findings support the use of home phototherapy. Parents felt secure at home with their infants and emphasised the importance of clear information and round-the-clock access to hospital staff.
| S-EPMC10676613 | biostudies-literature
Project description:BackgroundIndirect hyperbilirubinemia is frequently encountered during neonatal period. Although it has different causes, in some cases it can't be explained. Previous studies have illustrated that jaundice could be a major sign of urinary tract infection (UTI) in neonates.Aim of the workWe aimed to determine the association between UTI and significant unexplained neonatal indirect hyperbilirubinemia.MethodsThis prospective controlled study was performed on 150 neonates divided in two groups (100 as cases and 50 as controls) to investigate the incidence of UTI in neonates with significant unexplained hyperbilirubinemia. Urine sample was obtained using urine catheterization technique from neonates and full urine analysis was done and cases with pyuria had urine culture to confirm UTI. Immediate renal ultrasonography (USG) was performed for neonates with UTI.ResultsUTI incidence was 11% in cases while none of neonates in control group had UTI with statistical significance between cases and controls (P value < 0.05). The most common (36.4%) pathogen was Escherichia coli. Posterior urethral valve with mild hydronephrosis was diagnosed in 18.2% of UTI positive patients by renal ultrasonography.ConclusionIn neonates with unexplained indirect hyperbilirubinemia, UTI should be considered as a pathological cause.
| S-EPMC7891145 | biostudies-literature
Project description: Not available
| S-EPMC8259558 | biostudies-literature
Project description:BackgroundHome phototherapy (HPT) remains a contentious alternative to inpatient phototherapy (IPT) for neonatal hyperbilirubinemia. To guide evidence-based clinical decision-making, we conducted a meta-analysis of randomized clinical trials (RCTs) and cohort studies and assessed the comparative risks and benefits of HPT and IPT.MethodsPubMed, Embase, Web of Science, Cochrane Library, Chinese National Knowledge Infrastructure Database, Wanfang Database, Chinese Science and Technique Journals Database, ClinicalTrials.gov, and International Clinical Trial Registry Platform trial were searched from inception until June 2, 2023. We included RCTs and cohort studies and adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Study quality was assessed with the Cochrane Collaboration Risk of Bias tool and the Newcastle-Ottawa scale. The outcome measures were phototherapy duration, daily bilirubin level reduction, exchange transfusion, hospital readmission, parental stress scale, and complications. We used fixed- or random-effects meta-analysis models, assessed heterogeneity (I2), conducted subgroup analyses, evaluated publication bias, and graded evidence quality.ResultsNine studies (998 patients) were included (four RCTs, five cohort studies). HPT was associated with longer phototherapy duration (SMD = 0.55, 95% CI: 0.06-1.04, P = 0.03). Cohort study subgroup analysis yielded consistent results (SMD = 0.90; 95% CI: 0.69 to 1.11, P < 0.001, I2 = 39%); the RCTs were not significantly different (SMD = -0.04; 95% CI: -0.15 to 0.08, P = 0.54, I2 = 0%). Hospital readmission was higher with HPT (RR = 4.61; 95% CI: 1.43-14.86, P = 0.01). Daily bilirubin reduction (WMD = -0.12, 95% CI: -0.68 to 0.44, P = 0.68) or complications were not significantly different (RR = 2.29; 95% CI: 0.31-16.60, P = 0.41). The evidence quality was very low. HPT was associated with lower parental stress (SMD = -0.44, 95% CI: -0.71 to -0.16, P = 0.002). None of three included studies reported exchange transfusion.ConclusionsThe current evidence does not strongly support HPT efficacy for neonatal hyperbilirubinemia, as high-quality data on long-term outcomes are scarce. Future research should prioritize well-designed, large-scale, high-quality RCTs to comprehensively assess HPT risks and benefits.
| S-EPMC10910825 | biostudies-literature