Long term follow-up after intrauterine transfusion

Long term follow-up after intrauterine transfusion - LOTUS study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31534

Enrollment

800

Registered

2008-08-07

Start date

2008-07-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhesus-baby Severe anemia with intrauterine transfusion of the fetus

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Mothers and their live offspring who were treated with intrauterine transfusion.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
1. Identify, in the heavily RBC alloimmunized population of females after HDN treatment whether particular MHC class II alleles are associated with presence or absence of particular RBC immunization. 2. Determine the long-term neuromotor development, cognitive development and psychosocial well-being in a large group of children treated with IUT for fetal anemia.	—

Secondary

Measure	Time frame
1. Role of chimerism: investigate whether antibodies that had been identified after delivery still persist and whether the fetus or the IUT donor (or both) had provided the offending antigen. Evaluate whether fetal and/or donor chimerism is associated with persistence of RBC antibodies. 2. High and low respondership: investigate whether females, who produced multiple additional red cell antibodies, are high responders against HLA and HPA antigens as well. 3. Other genetic factors: investigate whether polymorphic genes relevant for co-stimulatory APC-T cell activation and T-B cell interactions determine occurrence of RBC allo-immunization. This subquestion is joined together with a wider investigation in other cohorts of immunized patients (Match-study) and carried out in collaboration with Prof. vd Schoot. 4. Long-tern outcome: explore the association of adverse long-term outcome with risk factors, including: gestational age at birth, cause and severity of fetal anemia, presence and severity of hydrops fetalis, and number of IUT procedures. 5. Long-term health effects: a protocolled questionnaire aiming to identify possible immune deviations as a result from the treatment (autoimmune diseases)	—

Measure

Time frame

1. Role of chimerism: investigate whether antibodies that had been identified after delivery still persist and whether the fetus or the IUT donor (or both) had provided the offending antigen. Evaluate whether fetal and/or donor chimerism is associated with persistence of RBC antibodies. 2. High and low respondership: investigate whether females, who produced multiple additional red cell antibodies, are high responders against HLA and HPA antigens as well. 3. Other genetic factors: investigate whether polymorphic genes relevant for co-stimulatory APC-T cell activation and T-B cell interactions determine occurrence of RBC allo-immunization. This subquestion is joined together with a wider investigation in other cohorts of immunized patients (Match-study) and carried out in collaboration with Prof. vd Schoot. 4. Long-tern outcome: explore the association of adverse long-term outcome with risk factors, including: gestational age at birth, cause and severity of fetal anemia, presence and severity of hydrops fetalis, and number of IUT procedures. 5. Long-term health effects: a protocolled questionnaire aiming to identify possible immune deviations as a result from the treatment (autoimmune diseases)

—

Countries

Netherlands

Outcome results