- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02686255
Hemoglobin Trend in Neonates and Toddlers Post Cardiac Surgery
August 28, 2018 updated by: Rabin Medical Center
Many toddlers and children are released home with relatively low hemoglobin levels following cardiac surgery, and with no careful follow up, at an age at which anemia is common.
At this age, breast milk and its substitute do not provide enough iron, and parents are not adherent enough to iron supplements.
Due to these facts, there is high importance, especially in children suffering from heart defects, for close follow up on their hemoglobin levels.
Studies following hemoglobin trend post cardiac surgery were never done with children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For the past 6 decades, children have been going through cardiac surgery to correct congenital heart defects.
Over the years, there has been great improvement in morbidity and mortality post cardiac surgery due to better technical skill and post operative treatment.
Most of those surgeries require cardio-pulmonary bypass machine, which requires the use of blood products, and many of those children also require blood product as part of the post operative care, especially those children with cyanotic heart defects.
Many toddlers and children are released home with relatively low hemoglobin levels, and with no careful follow up, at an age at which anemia is a risk factor for developmental delay and decreased cognitive function.
Iron deficiency is common in Israel among children aged 6-24 months.
At this age, breast milk and its substitute do not provide enough iron, and parents are not adherent enough to iron supplements as recommended by the ministry of health.
Due to these facts, there is high importance, especially in children suffering from heart defects, for close follow up on their hemoglobin levels.
In adults, a study following hemoglobin levels post cardiac surgery during hospitalization only, showed that most (79%) starting showing improvement during their hospitalization.
Another study in patients over the age of 50 post coronary artery bypass graft, showed no difference between a group receiving iron supplements and another not receiving any, after 2 months.
Similar studies were never done with children.
Study Type
Observational
Enrollment (Actual)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Petaẖ Tiqwa, Israel
- Rabin Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All children 0-18 months going through cardiac surgery during the 3 years of the study
Description
Inclusion Criteria:
- All children 0-18 months going through cardiac surgery during the 3 years of the study, after obtaining written consent from the parents/legal guardians.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children 0-18 months post heart surgery
complete blood count for all children 0-18 months going through cardiac surgery
|
complete blood count during follow up in the heart institute
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hemoglobin levels (mg/dL) during follow up of cardiac surgery, sampled by finger prick
Time Frame: 3 Years
|
3 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gilad Sherman, MD, Schneider's Children Medical Center of Israel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
January 28, 2016
First Submitted That Met QC Criteria
February 14, 2016
First Posted (Estimate)
February 19, 2016
Study Record Updates
Last Update Posted (Actual)
August 29, 2018
Last Update Submitted That Met QC Criteria
August 28, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0655-15-RMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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