The No IntraCranial Haemorrhage (NOICH) Study

ISRCTN	ISRCTN29462550
DOI	https://doi.org/10.1186/ISRCTN29462550
Secondary identifying numbers	NTR248

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 13/10/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr D. Oepkes
Scientific

Leiden University Medical Centre
Department of Obstetrics
K6-31, P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 5263360
Email	D.Oepkes@lumc.nl

Study information

Study design	Multicentre randomised single-centre active-controlled parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Intravenous immunoglobulin (IvIG) in the treatment of foetal or neonatal alloimmune thrombocytopenia: a prospective, multicentre, randomised trial comparing 0.5 g and 1.0 g IvIG per kilogram bodyweight per week
Study acronym	NOICH (No IntraCranial Haemorrhage)
Study objectives	The hypothesis is that 0.5 g/kg/wk of IvIG is as effective as 1.0 g/kg/wk, in the prevention of intracranial haemorrhage (ICH) in foetal or neonatal alloimmune thrombocytopenia (FNAIT).
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Foetal or neonatal alloimmune thrombocytopenia
Intervention	Study group: low dose IvIG (0.5 g/kg/wk) control group: standard treatment: high dose IvIG (1.0 g/kg/wk)
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Intravenous immunoglobulin (IvIG)
Primary outcome measure	Number of neonates with intracranial haemorrhage.
Secondary outcome measures	1. Cord blood platelet count at birth 2. 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
Overall study start date	01/01/2005
Completion date	30/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	212
Key inclusion criteria	1. Pregnant women with a subsequent pregnancy after prior pregnancy complicated by HPA alloimmunisation who have given birth to a child with a platelet count less than 150 x 10^9/l in the first week of life 2. HPA alloimmunisation must have been confirmed by the presence of maternal anti-HPA antibodies and the offending HPA antigen in the foetus 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 foetus 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
Key exclusion criteria	1. Pregnant women with autoimmune thrombocytopenia 2. Twins or multiple pregnancies 3. Foetuses and neonates with major congenital anomalies or chromosomal abnormalities 4. Women who have previously given birth to children with FNAIT with ICH 5. Women who have antibodies in the first pregnancy (discovered by chance, or for instance with a sister with FNAIT)
Date of first enrolment	01/01/2005
Date of final enrolment	30/01/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Centre

Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (Netherlands)
University/education

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website	http://www.lumc.nl/
"ROR"	https://ror.org/027bh9e22

Funders

Funder type

Research organisation

Sanquin Bloodbank Amsterdam (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan