|- candidate number||1428|
|- NTR Number||NTR248|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||7-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||The NOICH Study.|
|- Scientific Title||Intravenous immunoglobulin in the treatment of fetal or neonatal alloimmune thrombocytopenia. A prospective, multicentre, randomized trial comparing
0.5 g and 1.0 g IvIG per kilogram bodyweight per week.|
|- ACRONYM||NOICH (No IntraCranial Hemorrhage)|
|- hypothesis||The hypothesis is that 0.5 g/kg/wk of IvIG is as effective as 1.0 g/kg/wk, in the prevention of ICH in FNAIT.|
|- Healt Condition(s) or Problem(s) studied||Neonatal alloimmune thrombocytopenia , Immunoglobulin, Fetal alloimmune thrombocytopenia|
|- Inclusion criteria||1. Pregnant women with a subsequent pregnancy after prior pregnancy complicated by HPA alloimmunization who have given birth to a child with a platelet count < 150 x 10 9/l in the first week of life; |
2. HPA alloimmunization must have been confirmed by the presence of maternal anti-HPA antibodies and the offending HPA antigen in the fetus or homozygous partner;
3. The biological fathers are either homozygous positive for the HPA-type or heterozygous;
4. In the case of a heterozygous father the platelet antigen genotype of the fetus will be tested before 28 weeks by amniocentesis;
5. At inclusion, the pregnancy is an ultrasonographically proven intrauterine singleton pregnancy with a gestational age between 12 and 28 weeks;
6. All participating patients will give written informed consent after oral and written trial information.
|- Exclusion criteria||1. Pregnant women with autoimmune thrombocytopenia; |
2. Twins or multiple pregnancies;
3. Fetuses and neonates with major congenital anomalies or chromosomal abnormalities;
4. Women who have previously given birth to children with FNAIT with ICH. Women who have antibodies in the first pregnancy (discovered by chance, or for instance with a sister with FNAIT).
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jan-2005|
|- planned closingdate||30-jan-2008|
|- Target number of participants||212|
|- Interventions||Study group: low dose IvIG (0.5 g/kg/wk);
Control group, standard treatment: high dose IvIG (1.0 g/kg/wk).
|- Primary outcome||Number of neonates with intracranial hemorrhage.|
|- Secondary outcome||Cord blood platelet count at birth.|
Other variables studied will be the levels of maternal and neonatal anti-HPA antibodies and IgG, the occurrence of other bleedings in the neonate as well as the necessity and type of neonatal treatment.
|- Trial web site||http://www.noich.org|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. D. Oepkes|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. D. Oepkes|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Obstetrics|
(Source(s) of Monetary or Material Support)
|Sanquin Bloodbank Amsterdam|
|- Brief summary||The major complication of fetal or neonatal alloimmune thrombocytopenia (FNAIT) is intra cranial hemorrhage (ICH) in the child, resulting in severe morbidity or death. |
There are both clinical and experimental indications that intravenous immunoglobulines (IvIG) prevents ICH in the fetus and newborn.
Since the first reported study of treating pregnant women with FNAIT with IvIG, the most commonly used dose has been 1 gram per kilogram bodyweight per week (g/kg/wk). I
n one study corticosteroids were added and in another study 2 g/kg/wk has been administered, without apparent benefit (Bussel, 2001; Bussel, 1996).
Given the lack of rationale for the dose of 1 g/kg/wk, the cost of IvIG and the unknown long-term effects of IvIG on the infants, we plan to compare a lower dose with the standard dose IvIG.
The aim of this study is to compare the preventive effect of 0.5 with 1.0 g/kg/week IvIG on FNAIT and ICH, using an international multi-center, randomized controlled trial in patients with FNAIT and a low risk for ICH.
|- Main changes (audit trail)|
|- RECORD||6-sep-2005 - 21-jan-2011|