HemangiomaNCT00433940
Immune Suppression Of Infants Treated With Steroids
An observational study of Hemangioma, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Hemangioma
- What is being tested?
- Prednisolone
- Type of treatment
- Pill or oral medicine
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Subjects were recruited from a hospital based pediatric dermatology clinic.
Who may be able to join
- Infants < 6 months of age with infantile hemangiomas requiring treatment with oral corticosteroids
- Infant must be enrolled prior to initiation of steroid therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study
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.
Read the 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.
- Conditions
- Hemangioma
- Being tested
- Prednisolone
- Keywords
- Hemangioma, Corticosteroid, Prednisone
- Medical subject headings
- Hemangioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Also called steroid
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 group | Role | What they receive |
|---|---|---|
| Infantile Hemangioma Patients | Infants with infantile hemangioma being treated clinically with oral prednisolone sodium phosphate suspensions. Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency)
Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2007 (estimated)
- Study startOct 2006
- Primary completionApr 2008
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemangiomaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Drolet, Medical College of Wisconsin
- Investigators
- Beth A Drolet, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433940
- Sponsor's protocol ID
- Immune Suppression of Infants
- Status last verified
- Jan 2013
- First submitted
- 9 Feb 2007
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study
- ClinicalTrials.gov ID
- NCT00433940
- Acronym / sponsor ID
- Immune Suppression of Infants
- Conditions
- Hemangioma
- Keywords
- Hemangioma, Corticosteroid, Prednisone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infantile Hemangioma Patients | – | Drug: PrednisoloneInfants with infantile hemangioma being treated clinically with oral prednisolone sodium phosphate suspensions. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects were recruited from a hospital based pediatric dermatology clinic.
Key inclusion criteria (2 listed)
- Infants < 6 months of age with infantile hemangiomas requiring treatment with oral corticosteroids
- Infant must be enrolled prior to initiation of steroid therapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoloneAlso: steroidOral prednisolone sodium phosphate suspension administered in dosage of 15mg/5mL. Medication administered every morning at a starting daily dose of 2.5mg/kg. | Drug | Infantile Hemangioma Patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth A Drolet, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemangioma, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.