Hemoglobin Trend in Neonates and Toddlers Post Cardiac Surgery

Completed

• Conditions: Congenital Cardiac Defects
• Interventions: Other: complete blood count

• Registration Number: NCT02686255
• Lead Sponsor: Rabin Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-02-14
• Study First Posted: 2016-02-19
• Study Start: 2016-05
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children 0-18 months post heart surgery	complete blood count	complete blood count for all children 0-18 months going through cardiac surgery

Primary Outcome Measures

Name	Time	Method
Hemoglobin levels (mg/dL) during follow up of cardiac surgery, sampled by finger prick	3 Years

Trial Locations

Locations (1)

Rabin medical center; 🇮🇱 Petaẖ Tiqwa, Israel