IMMUNOGLOBULINS ANTI PLATELETS IN BREAST MILK OF MATERNAL ITP
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- IMMUNOGLOBULINS ANTI PLAITLETS IN BREST MILK OF MATERNAL ITP
Study Overview
Brief Summary
The purpose of this study is to determine whether mothers with Idiopathic thrombocytopenic purpura (ITP) has antibodies against platelets in breastfeeding milk aside control group of healthy mothers.
In order to prevent severe thrombocytopenia in infants born to mothers with ITP.
Detailed Description
Samples of breastfeeding milk and sera will be collected from 10 lactating women diagnosed with ITP and from 10 healthy women in the same stage after giving birth. Antibodies against platelets in the samples will be examined by using anti human IgM/G/A antibody following incubation of the serum/milk samples with platelets. The platelets will be from leftovers of samples send to platelets functionality test and found to be normal (the platelets samples will be taken without any identification and be marked only with lab number). The measurement will be done by flow cytometer. Sample will be consider as positive when the signal will be greater than 2 fold of control samples standard deviation. In addition, the presence of antibodies in different times from the birth will be checked in breastfeeding milk and sera of ITP patients. If the milk proteins and lipids will disturb the exam, the immunoglobulins from the milk will be isolated using Ig isolation kit from plasma.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Maternal ITP
- •Newborns above 35W and above 2.5 kg
Exclusion Criteria
- •mothers who do not breast feeding
- •Thrombocytopenia from other reasons
Outcomes
Primary Outcomes
IMMUNOGLOBULINS ANTI PLAITLETS IN BREST MILK OF MATERNAL ITP
Time Frame: 4 times in the first month after delivery
Secondary Outcomes
No secondary outcomes reported
Investigators
Laniado Hospital
pediatric hemato-oncology
Laniado Hospital