Immune Suppression Of Infants Treated With Steroids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2010-07-31

Brief Summary

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The goal of this study is to clarify the degree of immune suppression in infants requiring therapy and to create guidelines for evaluation and prevention of infection in infants on oral steroids for hemangiomas.

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Detailed Description

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Infants with large or complicated hemangiomas are often treated systemically with oral steroids. The side effects of the drug on young infants has not been studied. The goal of this study is to clarify the degree of immune suppression in infants requiring therapy and to create guidelines for evaluation and prevention of infection in infants on oral steroids for hemangiomas. Prednisone will be started according to established standard of care. Visits will occur every four weeks for follow-up. There will be six blood draws from baseline to completion of study. Approximately up to 1 ½ teaspoons per blood sample will be drawn to test the strength of the infant's immune system. Participation in this study will last up to 14 months or until stabilization of the hemangioma. Evaluation will occur 12 weeks after discontinuing the steroid for its long-term effects on the immune system.

Conditions

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Hemangioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infantile Hemangioma Patients

Infants with infantile hemangioma being treated clinically with oral prednisolone sodium phosphate suspensions.

Prednisolone

Intervention Type DRUG

Oral prednisolone sodium phosphate suspension administered in dosage of 15mg/5mL. Medication administered every morning at a starting daily dose of 2.5mg/kg.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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steroid

Eligibility Criteria

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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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No