Primary Immune Deficiency
Conditions
Brief summary
This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.
Interventions
BIOLOGICALSubcutaneous IgG (SCIG)
Administered according to normal clinical practice
Sponsors
CSL Behring
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
Inclusion criteria
* Infants who received more than one dose of IgG by the subcutaneous route before the age of two years. * Consent of parent/guardian if required by institution/IRB.
Exclusion criteria
* Infants with protein losing conditions such as lymphangiectasis, nephrosis, S/P cardio-thoracic surgery requiring drainage tubes for more than 48 hrs, protein losing enteropathy. * Concomitant treatment with plasma, other blood products or IGIV while on SCIG. * Lack of consent by parent/guardian (if required by Institution/IRB). * Any other condition or treatment which, in the opinion of the local investigator, would interfere with obtaining valid results for that subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCIG use | 1 year | To describe the use of SCIG in infants below the age of two years in major academic medical centers and immunologists' practices in the US |
Secondary
| Measure | Time frame |
|---|---|
| Number of infants who received more than one dose of SCIG, then continued receiving IgG by a route other than SC | 1 year |
Countries
United States
Outcome results
None listed