NCT00433940

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

1.5 years

First QC Date

February 9, 2007

Last Update Submit

January 23, 2013

Conditions

Hemangioma

Keywords

HemangiomaCorticosteroidPrednisone

Outcome Measures

Primary Outcomes (1)

  • Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency)

    Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis.

    2 years

Study Arms (1)

Infantile Hemangioma Patients

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

Drug: Prednisolone

Interventions

PrednisoloneDRUG

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

Also known as: steroid
Infantile Hemangioma Patients

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Subjects were recruited from a hospital based pediatric dermatology clinic.

You may qualify if:

  • Infants \< 6 months of age with infantile hemangiomas requiring treatment with oral corticosteroids
  • Infant must be enrolled prior to initiation of steroid therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: NONE RETAINED

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

MeSH Terms

Conditions

Hemangioma

Interventions

PrednisoloneSteroids

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Beth A Drolet, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 12, 2007

Study Start

October 1, 2006

Primary Completion

April 1, 2008

Study Completion

July 1, 2010

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)