Immune Suppression Of Infants Treated With Steroids
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00433940 |
Recruitment Status
:
Completed
First Posted
: February 12, 2007
Last Update Posted
: January 24, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Hemangioma | Drug: Prednisolone |
Study Type : | Observational |
Actual Enrollment : | 16 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | July 2010 |

Group/Cohort | Intervention/treatment |
---|---|
Infantile Hemangioma Patients
Infants with infantile hemangioma being treated clinically with oral prednisolone sodium phosphate suspensions.
|
Drug: Prednisolone
Oral prednisolone sodium phosphate suspension administered in dosage of 15mg/5mL. Medication administered every morning at a starting daily dose of 2.5mg/kg.
Other Name: steroid
|
- Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency) [ Time Frame: 2 years ]Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis.
Biospecimen Retention: None Retained

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 6 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Infants < 6 months of age with infantile hemangiomas requiring treatment with oral corticosteroids
- Infant must be enrolled prior to initiation of steroid therapy
Exclusion Criteria:
- Infants > 6 months of age
- Infants already receiving oral corticosteroid treatment prior to the start of this study
- Infants with know immunodeficiencies
- Infants receiving other oral medications for the treatment of hemangiomas

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433940
United States, Wisconsin | |
Children's Hospital of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Principal Investigator: | Beth A Drolet, MD | Medical College of Wisconsin |
Responsible Party: | Beth Drolet, MD, Medical College of Wisconsin |
ClinicalTrials.gov Identifier: | NCT00433940 History of Changes |
Other Study ID Numbers: |
Immune Suppression of Infants |
First Posted: | February 12, 2007 Key Record Dates |
Last Update Posted: | January 24, 2013 |
Last Verified: | January 2013 |
Keywords provided by Beth Drolet, Medical College of Wisconsin:
Hemangioma Corticosteroid Prednisone |
Additional relevant MeSH terms:
Hemangioma Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Prednisolone acetate Methylprednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |