neonatal hemochromatosis
Conditions
Interventions
IVIG, 1 g/kg body weight (maximum dose should be 60 g/body), at 14th, 16th weeks of gestation biweekly and weekly from the 18th week until the end of gestation
Sponsors
Sasaki Aiko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)Pregnant women who have delivered a baby diagnosed with neonatal hemochromatosis (2)Pregnant women between the ages of 16 and 45 at the time of obtaining consent (3)Pregnant women who are able to visit the hospital regularly throughout the study period (4)Pregnant women who have obtained written consent to participate in the study
Exclusion criteria
Exclusion criteria: (1)Women with a history of shock or hypersensitivity to the components of the investigational drug (2)Women who have been diagnosed with IgA deficiency in the past or women who have serum IgA levels of less than 5 mg/dL in clinical tests during the screening period (3)Women with a history of thromboembolism (4)Women with a history of either myocardial infarction or cerebral infarction (5)Women who showed abnormal findings on ST-T waves on electrocardiograms during the screening period and were clinically suspected of ischemic heart disease (6)Women with impaired heart function (7)Women with hereditary fructose intolerance (8)Women with hemolytic or blood loss anemia (9)Women with immunodeficiency or immunosuppression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of alive babies who have not had any of these treatments; postnatal IVIG, exchange transfusion, hemodialysis filtration, plasma apheresis and liver transplantation at 3 months after birth | — |
Contacts
Public ContactMayumi Sako
National Center for Child Health and Development
Outcome results
None listed