Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease

Rosenfeld, Warren; Ruiz, Nancy; Gautam, Shiva; Alissa, Rana; Banfro, Francis; Barringham, A.; Bettica, Linda; Bimbi, R.; Brown, Aisling; Camp, L. G.; Chakraborty, Bijan; Clark, Lisa J.; Crawford, S.; Dhanireddy, Ramasubbareddy; Eldemerdash, Ahmed; Fofah, Onajovwe; Ryan, Gerard; Hanna, Nader; Hudak, Mark L.; Jewell, Ann; Katof, N.; Kehinde, F. D.; Kicklighter, Stephen D.; Kim, J.; Maddox, A.; Maduekwe, Echezona T.; Meloy, Linda; Nason, Jennifer; Pollock, Kevin; Reyes, Diego; Richter, Susan E.; Shafi, Nadia; Shattuck, Karen E.; Smith, P. Brian; Stewart, Dan L.; Thomas, Melanie B.; Wagner, C.I.; Wong, WS

doi:10.1038/s41372-021-01223-2

Cited by 5 publications

(13 citation statements)

References 34 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…We identified 120 studies that were entered into Cochrane CENTRAL 2017 to 2021 and met our inclusion criteria (eFigure 1 in Supplement 1). There was a range in the articles’ availability via electronic publication (2016-2021) and publication year (2017-2023).…”

Section: Resultsmentioning

confidence: 99%

Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials

Lyle,

Shaikh,

Oslin

et al. 2023

JAMA Netw Open

View full text Add to dashboard Cite

ImportanceRepresentativeness of populations within neonatal clinical trials is crucial to moving the field forward. Although racial and ethnic disparities in research inclusion are well documented in other fields, they are poorly described within neonatology.ObjectiveTo describe the race and ethnicity of infants included in a sample of recent US neonatal clinical trials and the variability in this reporting.Evidence ReviewA systematic search of US neonatal clinical trials entered into Cochrane CENTRAL 2017 to 2021 was conducted. Two individuals performed inclusion determination, data extraction, and quality assessment independently with discrepancies adjudicated by consensus.FindingsOf 120 studies with 14 479 participants that met the inclusion criteria, 75 (62.5%) included any participant race or ethnicity data. In the studies that reported race and ethnicity, the median (IQR) percentage of participants of each background were 0% (0%-1%) Asian, 26% (9%-42%) Black, 3% (0%-12%) Hispanic, 0% (0%-0%) Indigenous (eg, Alaska Native, American Indian, and Native Hawaiian), 0% (0%-0%) multiple races, 57% (30%-68%) White, and 7% (1%-21%) other race or ethnicity. Asian, Black, Hispanic, and Indigenous participants were underrepresented, while White participants were overrepresented compared with a reference sample of the US clinical neonatal intensive care unit (NICU) population from the Vermont Oxford Network. Many participants were labeled as other race or ethnicity without adequate description. There was substantial variability in terms and methods of reporting race and ethnicity data. Geographic representation was heavily skewed toward the Northeast, with nearly one-quarter of states unrepresented.Conclusions and RelevanceThese findings suggest that neonatal research may perpetuate inequities by underrepresenting Asian, Black, Hispanic, and Indigenous neonates in clinical trials. Studies varied in documentation of race and ethnicity, and there was regional variation in the sites included. Based on these findings, funders and clinical trialists are advised to consider a 3-point targeted approach to address these issues: prioritize identifying ways to increase diversity in neonatal clinical trial participation, agree on a standardized method to report race and ethnicity among neonatal clinical trial participants, and prioritize the inclusion of participants from all regions of the US in neonatal clinical trials.

show abstract

Section: Resultsmentioning

confidence: 99%

Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials

Lyle,

Shaikh,

Oslin

et al. 2023

JAMA Netw Open

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 99%

“…In contrast to an animal study [ 15 ], human neonatal study demonstrated that escalating doses may not necessarily decrease total plasma bilirubin levels in dose-dependent manner [ 35 , 36 ]. Rather, a prolonged sustained low level of bilirubin was observed, similar to the animal study [ 15 ], although still significantly lower than the control group [ 35 , 37 ]. This inferred that the profound inhibitory effect of Sn-MP is only evident by 24 to 48 hours with the initial sharp decline [ 38 ], but significant difference in bilirubin levels compared to the control group occurs only at three to five days posttreatment.…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, a single adjunct dose of Sn-MP also resulted in a marked reduction of both the need and duration of phototherapy or even elimination of the need for phototherapy [35][36][37][39][40][41]. Additionally, Sn-MP also benefited as a prophylactic therapy in glucose-6-phosphate dehydrogenase-(G6PD-) deficient neonates, sustaining low bilirubin levels and lowering the need and duration for phototherapy [42,43].…”

Section: Human Studies With Sn-mesoporphyrinmentioning

confidence: 99%

“…Reports with safety concerns Drummond et al [18] Hintz et al [23] Drummond and Kappas [19] DeSandre et al [20] Fort and Gold [24] Morioka et al [21] Wong et al [22] Vreman et al [25] Rosenfeld et al [35] Rosenfeld et al [36] Bhutani et al [37] Maisels and Yang [38] Valaes et al [39] Kappas et al [40] Martinez et al [41] Valaes et al [42] Kappas et al [43] Case reports: Kappas et al [32] Rubaltelli et al [33] Galbraith et al [34] Maisels and Yang [38]…”

Section: Reports Favoring Efficacymentioning

confidence: 99%

See 2 more Smart Citations

Efficacy and Safety Concerns with Sn-Mesoporphyrin as an Adjunct Therapy in Neonatal Hyperbilirubinemia: A Literature Review

Poudel

Adhikari

2022

International Journal of Pediatrics

View full text Add to dashboard Cite

Neonatal hyperbilirubinemia is a frequently observed clinical situation that, sometimes, may result in complications ranging from mild neurodevelopment impairment to serious outcome of kernicterus. The rationale logic of heme oxygenase enzyme inhibition to lower bilirubin levels is intriguing. In compliance with that rationale, metalloporphyrin was discovered. After successful results in in-vitro and animal studies, tin mesoporphyrin is now under phase II clinical trial to test for preventive and therapeutic efficacy in unconjugated hyperbilirubinemia. This review evaluates in-vitro studies, animal studies, and clinical trials for the efficacy and safety of tin analogues of metalloporphyrin. Few alternatives to metalloporphyrins are also available, synchronizing with the same rationale logic of inhibition of bilirubin production, which need further research.

show abstract