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Completed

NCT Number: NCT02686255

Hemoglobin Trend in Neonates and Toddlers Post Cardiac Surgery

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.

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Key information

Age range

Up to 18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Rabin medical center

Petah Tikva, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

complete blood count

Other

complete blood count during follow up in the heart institute

Primary outcomes

  1. Hemoglobin levels (mg/dL) during follow up of cardiac surgery, sampled by finger prick

    Time frame: 3 Years

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2016
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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