Hemoglobin Trend in Neonates and Toddlers Post Cardiac Surgery

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Clalit Health Services

Status

Completed

Conditions

Congenital Cardiac Defects

Treatments

Other: complete blood count

Study type

Observational

Funder types

Other

Identifiers

NCT02686255
0655-15-RMC

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 patients

Sex

All

Ages

Under 18 months old

Volunteers

No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

Children 0-18 months post heart surgery
Description:
complete blood count for all children 0-18 months going through cardiac surgery
Treatment:
Other: complete blood count

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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