AnemiaNCT00459225
Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease
A study testing Iron (ferrous sulfate) in people with Anemia, run by Emory University at 1 site in United States.
Trial summary
Anemia is a common disorder in infants with one working chamber of the heart that pumps blood. Anemia is when the level of healthy blood cells becomes too low. This may cause other health problems because red blood cells contain hemoglobin, which carries oxygen (needed for survival) to different parts of the body. Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Anemia
- What is being tested?
- Iron (ferrous sulfate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jun 2013
- Phase
- Interventional
- 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 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Single ventricle physiology (hypoplastic left heart syndrome [HLHS], tricuspid atresia, double inlet left ventricle [DILV], some double outlet right ventricle [DORV], heterotaxy, etc.)
- Age less than or equal to 2 months
- Saturations less than or equal to 90%
- Tolerating enteral feeds
- Informed consent being obtained
Who cannot join
- Age > 2 months
- Saturations > 90%
- Total parenteral nutrition
- Chronic kidney disease
- Prior iron therapy
- Hemolytic anemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30312
About this study
Official title: Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease: An Open Label Trial
Anemia is a common disorder in infants with one working chamber of the heart that pumps blood. Anemia is when the level of healthy blood cells becomes too low. This may cause other health problems because red blood cells contain hemoglobin, which carries oxygen (needed for survival) to different parts of the body.
This study will look at the role of iron in preventing anemia in infants with one pumping chamber. The importance of iron therapy will be examined.
Hypothesis: Prophylactic use of iron in infants with single ventricle is effective in preventing anemia.
Read the detailed description
At the beginning of the study, subjects will be randomized to two different groups. One group will receive iron every day for the next 4 months or so (up until their Glenn surgery); the other group will not receive any iron. Those in the iron treatment arm of the study will receive iron education at discharge from their first stage surgery (Norwood or BTS surgery) and will be given vials of iron to take home. A patient will receive a set amount of iron (dose will be 3 mg/kg) once a day. Weekly follow-up phone calls will be conducted by study personnel to re-calculate dose of iron for parents (based on weight) as well as check on the status of the research subject.
Group II will not receive iron but will be a participant in the study and follow the course of the non-iron randomized patients.
Blood samples will also be drawn at the same time as standard of care labs at two time points during the course of the study for both groups of patients. Blood for iron study labs will be drawn at 72 hours prior to discharge from the first stage surgery and at the pre-Glenn screening. A reticulocyte count test will also be done at the pre-Glenn screening. These lab tests look at the number of red blood cells in the body, the type of red blood cells, their ability to carry oxygen and the iron status of the research subject. Additionally, data will be collected on the CBC count, subject's age, weight, pulse oximetry, surgical history, transfusion history, iron levels and therapy, and hematological indices (Hgb, Hct, MCV, RDW, RBC count, and reticulocyte count), as well as peripheral blood smear. Feeding history will be carefully documented. Descriptive demographic data and underlying diagnosis will be collected, along with all the above variables defined.
The hemoglobin and iron levels at the time of pre-Glenn labs will be compared to those at the start of the study. The importance of iron therapy will be examined.
Iron is a readily available medicine for both the prevention and treatment of anemia. If this simple cost-effective medicine can decrease the prevalence of anemia in these infants, it may result in more oxygen to the body's tissues and areas, less stress on the single pumping chamber of the heart and it may also improve their overall growth and development.
- Primary Aim - To achieve a higher hemoglobin level at time of second stage surgery (Glenn procedure).
- Secondary Aims - To obtain the following outcomes:
- Increased ferritin levels
- Decreased interval blood transfusions
- Normal MCV (red cell volume) and RDW (red cell distribution)
- Conditions
- Anemia
- Being tested
- Iron (ferrous sulfate)
- Keywords
- Pediatrics, Cardiac Defect, Cardiac Surgery, Single Ventricle, Anemia, blood transfusions, red cell volume, red cell distribution, oral iron, ferrous sulfate, Congenital Cardiac Defects, Hemoglobin, Iron Deficiency
- Medical subject headings
- Anemia, Univentricular Heart, Heart Defects, Congenital, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron (ferrous sulfate)Drug
The subjects in the iron treatment arm of the study will receive 3 mg/kg of oral/enteral iron solution once a day beginning at the time of discharge until the pre-Glenn screening which is the endpoint of the study. The iron will be dispensed for the subjects upon discharge from the hospital. The subjects randomized to the no iron treatment arm and the patients in Group II of the study will not receive iron upon discharge. However, they may be started on iron therapy in an intent-to-treat anemia by their primary physician in which case this will serve as the endpoint of the study for these participants.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The parent/guardian will be educated on the iron study and provided the opportunity to ask questions. If the parent/guardian chooses to participate in the study, the parent/guardian will give informed consent for the patient to be placed in either Group I or Group II, based upon guardian/parents' choice for participation in the iron arm of the study. Group I will be randomized in a 1:1 ratio in this open label trial to either receive or not receive iron. Group II will not receive iron but will be a participant in the study and follow the course of the non-iron randomized patients. Receives: Drug: Iron (ferrous sulfate) |
| 2 | No intervention | Group II will not receive iron but will be a participant in the study and follow the course of the non-iron randomized patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete blood count, Iron study labs (ferritin, Total Iron Binding Capacity, and Iron lab) 72 hours prior to discharge following neonatal surgery
Measured: Discharge from hospital
Hemoglobin and Hematocrit at pre-Glenn catheterization
Measured: Will be assessed at the pre-Genn catheterization
Complete Blood count, Iron study labs, and Reticulocyte count at pre-glenn screening
Measured: Will be assessed at the pre-glenn screening
Secondary outcomes (1)
feeding regimen and transfusion history at 72 hours prior to discharge from neonatal surgery, at pre-Glenn catheterization, and at pre-Glenn screening
Measured: Will be assessed at the time of discharge, pre-Glenn catheterization and screening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Difficulty recruiting subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, William T. Mahle, MD, Emory University
- Investigators
- William Mahle, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459225
- Sponsor's protocol ID
- IRB00002287
- Status last verified
- Dec 2014
- First submitted
- 10 Apr 2007
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaemmerer H, Fratz S, Braun SL, Koelling K, Eicken A, Brodherr-Heberlein S, Pietrzik K, Hess J. Erythrocyte indexes, iron metabolism, and hyperhomocysteinemia in adults with cyanotic congenital cardiac disease. Am J Cardiol. 2004 Sep 15;94(6):825-8. doi: 10.1016/j.amjcard.2004.06.014.
PubMed 15374802Perloff JK, Rosove MH, Child JS, Wright GB. Adults with cyanotic congenital heart disease: hematologic management. Ann Intern Med. 1988 Sep 1;109(5):406-13. doi: 10.7326/0003-4819-109-5-406.
PubMed 3044212Perloff JK. Systemic complications of cyanosis in adults with congenital heart disease. Hematologic derangements, renal function, and urate metabolism. Cardiol Clin. 1993 Nov;11(4):689-99.
PubMed 8252568Felker GM, Shaw LK, Stough WG, O'Connor CM. Anemia in patients with heart failure and preserved systolic function. Am Heart J. 2006 Feb;151(2):457-62. doi: 10.1016/j.ahj.2005.03.056.
PubMed 16442914Dallman PR, Siimes MA, Stekel A. Iron deficiency in infancy and childhood. Am J Clin Nutr. 1980 Jan;33(1):86-118. doi: 10.1093/ajcn/33.1.86. No abstract available.
PubMed 6986756
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease: An Open Label Trial
- ClinicalTrials.gov ID
- NCT00459225
- Acronym / sponsor ID
- IRB00002287
- Conditions
- Anemia
- Keywords
- Pediatrics, Cardiac Defect, Cardiac Surgery, Single Ventricle, Anemia, blood transfusions, red cell volume, red cell distribution
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Study start
- Apr 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Apr 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.
Anemia is a common disorder in infants with one working chamber of the heart that pumps blood. Anemia is when the level of healthy blood cells becomes too low. This may cause other health problems because red blood cells contain hemoglobin, which carries oxygen (needed for survival) to different parts of the body.
This study will look at the role of iron in preventing anemia in infants with one pumping chamber. The importance of iron therapy will be examined.
Hypothesis: Prophylactic use of iron in infants with single ventricle is effective in preventing anemia.
Detailed description
At the beginning of the study, subjects will be randomized to two different groups. One group will receive iron every day for the next 4 months or so (up until their Glenn surgery); the other group will not receive any iron. Those in the iron treatment arm of the study will receive iron education at discharge from their first stage surgery (Norwood or BTS surgery) and will be given vials of iron to take home. A patient will receive a set amount of iron (dose will be 3 mg/kg) once a day. Weekly follow-up phone calls will be conducted by study personnel to re-calculate dose of iron for parents (based on weight) as well as check on the status of the research subject.
Group II will not receive iron but will be a participant in the study and follow the course of the non-iron randomized patients.
Blood samples will also be drawn at the same time as standard of care labs at two time points during the course of the study for both groups of patients. Blood for iron study labs will be drawn at 72 hours prior to discharge from the first stage surgery and at the pre-Glenn screening. A reticulocyte count test will also be done at the pre-Glenn screening. These lab tests look at the number of red blood cells in the body, the type of red blood cells, their ability to carry oxygen and the iron status of the research subject. Additionally, data will be collected on the CBC count, subject's age, weight, pulse oximetry, surgical history, transfusion history, iron levels and therapy, and hematological indices (Hgb, Hct, MCV, RDW, RBC count, and reticulocyte count), as well as peripheral blood smear. Feeding history will be carefully documented. Descriptive demographic data and underlying diagnosis will be collected, along with all the above variables defined.
The hemoglobin and iron levels at the time of pre-Glenn labs will be compared to those at the start of the study. The importance of iron therapy will be examined.
Iron is a readily available medicine for both the prevention and treatment of anemia. If this simple cost-effective medicine can decrease the prevalence of anemia in these infants, it may result in more oxygen to the body's tissues and areas, less stress on the single pumping chamber of the heart and it may also improve their overall growth and development.
- Primary Aim - To achieve a higher hemoglobin level at time of second stage surgery (Glenn procedure).
- Secondary Aims - To obtain the following outcomes:
- Increased ferritin levels
- Decreased interval blood transfusions
- Normal MCV (red cell volume) and RDW (red cell distribution)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Iron (ferrous sulfate)The parent/guardian will be educated on the iron study and provided the opportunity to ask questions. If the parent/guardian chooses to participate in the study, the parent/guardian will give informed consent for the patient to be placed in either Group I or Group II, based upon guardian/parents' choice for participation in the iron arm of the study. Group I will be randomized in a 1:1 ratio in this open label trial to either receive or not receive iron. Group II will not receive iron but will be a participant in the study and follow the course of the non-iron randomized patients. |
| 2 | No intervention | –Group II will not receive iron but will be a participant in the study and follow the course of the non-iron randomized patients. |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Single ventricle physiology (hypoplastic left heart syndrome [HLHS], tricuspid atresia, double inlet left ventricle [DILV], some double outlet right ventricle [DORV], heterotaxy, etc.)
- Age less than or equal to 2 months
- Saturations less than or equal to 90%
- Tolerating enteral feeds
- Informed consent being obtained
Key exclusion criteria (6 listed)
- Age > 2 months
- Saturations > 90%
- Total parenteral nutrition
- Chronic kidney disease
- Prior iron therapy
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 |
|---|---|---|
| Iron (ferrous sulfate)The subjects in the iron treatment arm of the study will receive 3 mg/kg of oral/enteral iron solution once a day beginning at the time of discharge until the pre-Glenn screening which is the endpoint of the study. The iron will be dispensed for the subjects upon discharge from the hospital. The subjects randomized to the no iron treatment arm and the patients in Group II of the study will not receive iron upon discharge. However, they may be started on iron therapy in an intent-to-treat anemia by their primary physician in which case this will serve as the endpoint of the study for these participants. | Drug | 1 |
Primary outcome
Complete blood count, Iron study labs (ferritin, Total Iron Binding Capacity, and Iron lab) 72 hours prior to discharge following neonatal surgery
Time frame: Discharge from hospital
Hemoglobin and Hematocrit at pre-Glenn catheterization
Time frame: Will be assessed at the pre-Genn catheterization
Complete Blood count, Iron study labs, and Reticulocyte count at pre-glenn screening
Time frame: Will be assessed at the pre-glenn screening
1 secondary outcome
feeding regimen and transfusion history at 72 hours prior to discharge from neonatal surgery, at pre-Glenn catheterization, and at pre-Glenn screening
Time frame: Will be assessed at the time of discharge, pre-Glenn catheterization and screening.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- Background: PubMed 15374802Kaemmerer H, Fratz S, Braun SL, Koelling K, Eicken A, Brodherr-Heberlein S, Pietrzik K, Hess J. Erythrocyte indexes, iron metabolism, and hyperhomocysteinemia in adults with cyanotic congenital cardiac disease. Am J Cardiol. 2004 Sep 15;94(6):825-8. doi: 10.1016/j.amjcard.2004.06.014.
- Background: PubMed 3044212Perloff JK, Rosove MH, Child JS, Wright GB. Adults with cyanotic congenital heart disease: hematologic management. Ann Intern Med. 1988 Sep 1;109(5):406-13. doi: 10.7326/0003-4819-109-5-406.
- Background: PubMed 8252568Perloff JK. Systemic complications of cyanosis in adults with congenital heart disease. Hematologic derangements, renal function, and urate metabolism. Cardiol Clin. 1993 Nov;11(4):689-99.
- Background: PubMed 16442914Felker GM, Shaw LK, Stough WG, O'Connor CM. Anemia in patients with heart failure and preserved systolic function. Am Heart J. 2006 Feb;151(2):457-62. doi: 10.1016/j.ahj.2005.03.056.
- Background: PubMed 6986756Dallman PR, Siimes MA, Stekel A. Iron deficiency in infancy and childhood. Am J Clin Nutr. 1980 Jan;33(1):86-118. doi: 10.1093/ajcn/33.1.86. No abstract available.
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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.
William Mahle, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron (ferrous sulfate) in people with Anemia, run by Emory University 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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 9 Dec 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
Complete blood count, Iron study labs (ferritin, Total Iron Binding Capacity, and Iron lab) 72 hours prior to discharge following neonatal surgery (time frame: Discharge from hospital). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00459225, which also lists 5 linked publications.
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 9 Dec 2014.