Intrauterine high-dose intravenous immunoglobulin therapy during pregnancy for women with a history of pregnancy ending in documented neonatal haemochromatosis (NH001): study protocol

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.

Short sleep duration is a significant risk factor of obesity: A multicenter observational study of healthy adults in Japan

by Mami Takahashi, Takeshi Shimamoto, Lumine Matsumoto, Yusuke Mitsui, Yukari Masuda, Hirotaka Matsuzaki, Eriko Hasumi, Chie Bujo, Keiko Niimi, Takako Nishikawa, Ryoichi Wada, Nobutake Yamamichi

This multicenter study aimed to elucidate the association between sleep duration and various lifestyle-related disorders in healthy adults in Japan. A total of 62,056 healthy participants (age: 49.4 ±  10.9 years) who received medical checkups from 2010 to 2020 were analyzed cross-sectionally and longitudinally. The mean sleep duration was 6.2 ±  1.0 h in men and 6.1 ±  1.0 h in women. The distribution of sleep duration showed that older people tended to sleep longer, which was clearly observed in men but not in women. Univariate analyses showed that older age, lower body mass index (BMI), habitual drinking, and habitual exercise were significantly associated with longer sleep duration. Multivariate analyses in men showed that sleep duration was positively associated with age, habitual exercise, serum triglyceride (TG), systolic blood pressure (SBP), and habitual drinking and negatively associated with BMI and hemoglobin A1c (HbA1c). Alternatively, in women, sleep duration was positively associated with habitual exercise and TG and negatively associated with BMI, high-density lipoprotein-cholesterol, HbA1c, and current smoking. During the follow-up period, 3,360 of 31,004 individuals (10.8%) developed obesity. The Cox proportional hazards model showed that shorter sleep duration was a significantly higher risk of obesity, and longer sleep duration might be a lower risk of obesity. On the other hand, 1,732 of 39,048 participants (4.4%) developed impaired glucose tolerance, and 6,405 of 33,537 participants (19.1%) developed hypertriglyceridemia. However, the Cox proportional hazards model did not show significant association between sleep duration and impaired glucose tolerance or hypertriglyceridemia. In conclusion, our large-scale cross-sectional study showed that sleep duration was positively associated with habitual exercise and TG and negatively associated with BMI and HbA1c, regardless of sex. Longitudinal analysis revealed that shorter sleep duration is a significant risk factor for obesity.