NCT02814539

Brief Summary

The purpose of the study is to determine whether the neurodevelopmental outcome and in particular executive functions in 9 to 14 year old school children with congenital heart disease who underwent cardiopulmonary bypass surgery during their first three months of life is impaired in comparison to healthy children at same age. Executive functions are higher order cognitive functions and critical for school success.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

3.5 years

First QC Date

June 23, 2016

Last Update Submit

September 24, 2019

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Executive Functions, assessed with D-KEFS

    2 years

Secondary Outcomes (2)

  • slow wave activity on EEG

    2 years

  • MRI volumetry

    2 years

Study Arms (2)

congenital heart disease

children with severe congenital heart disease who undergo open heart surgery during infancy

healthy controls

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

  • Congenital heart disease,
  • Cardiopulmonary bypass surgery during first three months of life,
  • No genetic syndrome,
  • Gestational age \> 37 weeks of gestation.

You may not qualify if:

  • Heart surgery without cardiopulmonary bypass,
  • Heart surgery not within first three months of life,
  • Born \<37 weeks of gestation,
  • Any genetic syndrome detected.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bea Latal, MD MPH

    University Childrens Hospital Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof Dr med Bea Latal

Study Record Dates

First Submitted

June 23, 2016

First Posted

June 27, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09