{
  "abstract": "Introduction Neonatal haemochromatosis, considered to be a gestational alloimmune liver disease (NH-GALD), is a rare but serious disease that results in fulminant hepatic failure. The recurrence rate of NH-GALD in a subsequent infant of a mother with an affected infant is 70%–90%. Recently, antenatal maternal high-dose intravenous immunoglobulin (IVIG) therapy has been reported as being effective for preventing recurrence of NH-GALD in a subsequent infant. However, no clinical trial has been conducted to date.Methods and analysis This is a multicentre open-label, single-arm study of antenatal maternal high-dose IVIG therapy in pregnant women with a history of documented NH in a previous offspring. The objective of this study is to evaluate the efficacy and safety of antenatal maternal high-dose IVIG therapy in preventing or reducing the severity of alloimmune injury to the fetal liver.Ethics and dissemination The clinical trial is being performed in accordance with the Declaration of Helsinki. The trial protocol was approved by the Clinical Research Review Board at four hospitals. Before enrolment, written informed consent would be obtained from eligible pregnant women. The results are expected to be published in a scientific journal.Protocol version 28 October 2024, V.8.0.Trial registration number jRCT1091220353.",
  "authors": [
    {
      "affiliations": [
        "Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan"
      ],
      "name": "Aiko Sasaki"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Kanazawa University, Kanazawa, Japan"
      ],
      "name": "Akihiro Yachie"
    },
    {
      "affiliations": [
        "Saitama Children’s Medical Center, Saitama, Saitama Prefecture, Japan"
      ],
      "name": "Koichi Mizuta"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Jichi Medical University, Shimotsuke, Japan"
      ],
      "name": "Hironori Takahashi"
    },
    {
      "affiliations": [
        "Department of Transplant Surgery, Jichi Medical University, Shimotsuke, Japan"
      ],
      "name": "Noriki Okada"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Kanazawa University, Kanazawa, Japan"
      ],
      "name": "Tomoko Toma"
    },
    {
      "affiliations": [
        "Department of Allergy and Clinical Immunology, National Center for Child Health and Development, Setagaya-ku, Japan"
      ],
      "name": "Kenichiro Motomura"
    },
    {
      "affiliations": [
        "Department of Allergy and Clinical Immunology, National Center for Child Health and Development, Setagaya-ku, Japan"
      ],
      "name": "Kenji Matsumoto"
    },
    {
      "affiliations": [
        "Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan"
      ],
      "name": "Yuka Sano Wada"
    },
    {
      "affiliations": [
        "Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan"
      ],
      "name": "Yushi Ito"
    },
    {
      "affiliations": [
        "Department of General Pediatrics, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan"
      ],
      "name": "Reiko Ito"
    },
    {
      "affiliations": [
        "National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan"
      ],
      "name": "Mureo Kasahara"
    },
    {
      "affiliations": [
        "Center for Organ Transplantation, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan"
      ],
      "name": "Akinari Fukuda"
    },
    {
      "affiliations": [
        "Showa University, Shinagawa-ku, Tokyo, Japan"
      ],
      "name": "Eisuke Inoue"
    },
    {
      "affiliations": [
        "Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan"
      ],
      "name": "Koshi Yamaguchi"
    },
    {
      "affiliations": [
        "Department of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan"
      ],
      "name": "Hidefumi Nakamura"
    },
    {
      "affiliations": [
        "Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan"
      ],
      "name": "Seiji Wada"
    },
    {
      "affiliations": [
        "Department of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan"
      ],
      "name": "Mayumi Sako"
    }
  ],
  "title": "Intrauterine high-dose intravenous immunoglobulin therapy during pregnancy for women with a history of pregnancy ending in documented neonatal haemochromatosis (NH001): study protocol",
  "uid": "590ad790-64ec-55fc-b805-c95f39062a71"
}