Immune Suppression Of Infants Treated With Steroids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beth Drolet, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00433940
First received: February 9, 2007
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Hemangioma
Drug: Prednisolone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis.


Biospecimen Retention:   None Retained

Collection of blood samples at each visit. Following laboratory testing, no samples were retained.


Enrollment: 16
Study Start Date: October 2006
Study Completion Date: July 2010
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects were recruited from a hospital based pediatric dermatology clinic.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433940

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Beth A Drolet, MD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Beth Drolet, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00433940     History of Changes
Other Study ID Numbers: Immune Suppression of Infants
Study First Received: February 9, 2007
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Hemangioma
Corticosteroid
Prednisone

Additional relevant MeSH terms:
Hemangioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014