Immune Suppression Of Infants Treated With Steroids

Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00433940

Enrollment

Registered

2007-02-12

Start date

2006-10-31

Completion date

2010-07-31

Last updated

2013-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemangioma

Keywords

Hemangioma, Corticosteroid, Prednisone

Brief summary

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.

Detailed description

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.

Interventions

DRUGPrednisolone

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency)	2 years	Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026