Immunoglobulins Anti Platelets In Breast Milk Of Maternal ITP

NCT ID: NCT01880801

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-08-31

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.

Conditions

Mothers With ITP Condition

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Maternal ITP
• Newborns above 35W and above 2.5 kg

Exclusion Criteria

• mothers who do not breast feeding
• Thrombocytopenia from other reasons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laniado Hospital

OTHER

Sponsor Role: lead

Responsible Party

Laniado Hospital

pediatric hemato-oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sharon Nechama, Laniado Hospital

Netanya, Israel, Israel

Countries

Israel

Facility Contacts

Nechama Sharone, MD

Role: primary

nsharon@laniado.org.il

972-544303356

Other Identifiers

006-12-LND

Identifier Type: -

Identifier Source: org_study_id