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Clinical trial of tin mesoporphyrin to prevent neonatal hyperbilirubinemia

Journal of Perinatology volume 36, pages 533–539 (2016)Cite this article

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Abstract

Objective:

To assess the efficacy of the heme oxygenase inhibitor, tin mesoporphyrin (SnMP), to reduce total bilirubin (TB) levels.

Study Design:

Masked, SnMP (4.5 mg kg−1), placebo-controlled, multicenter trial of single intramuscular injection to newborns ⩾35 weeks gestational age whose predischarge screening transcutaneous bilirubin (TcB) was >75th percentile.

Results:

Two hundred and thirteen newborns (median age 30 h) were randomized to treatment with SnMP (n=87) or ‘sham’ (n=89). We found that the duration of phototherapy was halved. Within 12 h of SnMP administration, the natural TB trajectory was reversed. At age 3 to 5 days, TB in the SnMP-treated group was +8% but sixfold lower than the 47% increase in the sham-treated group (P<0.001). At age 7 to 10 days, mean TB declined 18% (P<0.001) compared with a 7.1% increase among controls. No short-term adverse events from SnMP treatment were noted other than photoreactivity due to inadvertent exposure to white light phototherapy.

Conclusion:

Early, predischarge SnMP administration decreased the duration of phototherapy, reversed TB trajectory and reduced the severity of subsequent hyperbilirubinemia.

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Acknowledgements

We thank Dr Lois Johnson for continued support and guidance for this research project. Dr Bhutani and Dr Johnson served as the Site PI and co-site PI, respectively, for the study at Pennsylvania Hospital, Philadelphia, PA, USA. In addition, we are thankful to Dr David K Stevenson and Ronald J Wong for their reviews of the manuscript, helpful critiques and for continued contributions to this area of research. We appreciate the assistance of Rosemary Dworanzyck and Emidio M Sivieri to attain the quality control of data collection. We thank the research assistants, nurses and nurse practitioners for helping with jaundice assessments and patient education during 2002 to 2003: Newborn Nurseries at Well Baby Nursery, Pennsylvania Hospital, Philadelphia; Mother-Baby Unit Newborn Nursery, University of New Mexico Hospital, New Mexico; Doernbecher Newborn Nursery of Virginia Commonwealth University Health System, Virginia; Rainbow Childrens’ Hospital, Robert Wood Johnson Hospital and William Beaumont Hospital. We also thank Martin E Castillo Cuadrado for his administrative support at the Stanford University. We appreciate the contributions of Dr A Kappas, Dr JF Lucey as well as Dr R Yukovich and Dr B Levinson (of WellSpring Pharmaceutical Corporation) for their individual guidance and support during the initial study design. The study was partially funded by WellSpring Pharmaceutical Corporation (Neptune, NJ) in 2002 to 2003 who provided the drug, technical supplies, technician and research assistant support and study coordination with the FDA. The drug, SnMP, was provided as a clinical formulary, Stanate, through an investigational drug exemption to the clinical study. WellSpring Pharmaceutical Corporation no longer has publication authority on this manuscript.

Author contributions

Vinod K Bhutani, MD, FAAP, wrote the first draft of this manuscript.

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Authors and Affiliations

  1. Division of Neonatal–Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA

    V K Bhutani

  2. Department of Pediatrics, University of New Mexico, Albuquerque, NM, USA

    R Poland

  3. Department of Pediatrics, Virginia Commonwealth University, Richmond, VA, USA

    L D Meloy

  4. Department of Pediatrics, Robert Wood Johnson Hospital, New Brunswick, NJ, USA

    T Hegyi

  5. Department of Pediatrics, Rainbow Babies’ and Children’s Hospital, Cleveland, OH, USA

    A A Fanaroff

  6. Department of Pediatrics, William Beaumont Hospital, Royal Oak, MI, USA

    M J Maisels

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  1. V K Bhutani
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Correspondence to V K Bhutani.

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Bhutani, V., Poland, R., Meloy, L. et al. Clinical trial of tin mesoporphyrin to prevent neonatal hyperbilirubinemia. J Perinatol 36, 533–539 (2016). https://doi.org/10.1038/jp.2016.22

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