NCT02686255

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

January 28, 2016

Last Update Submit

August 28, 2018

Conditions

Congenital Cardiac Defects

Outcome Measures

Primary Outcomes (1)

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

    3 Years

Study Arms (1)

Children 0-18 months post heart surgery

complete blood count for all children 0-18 months going through cardiac surgery

Other: complete blood count

Interventions

complete blood countOTHER

complete blood count during follow up in the heart institute

Children 0-18 months post heart surgery

Eligibility Criteria

AgeUp to 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All children 0-18 months going through cardiac surgery during the 3 years of the study

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin medical center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Gilad Sherman, MD

    Schneider's children medical center of Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 19, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

August 29, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)