NCT01632813

Brief Summary

The key objective of the Leuven growing-into-deficit (GID) follow-up-study is to test the hypothesis that children with a congenital heart disease (CHD) show more neurocognitive impairment at the second follow-up at 7 years old than at the first follow-up at the age of 4, compared to healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

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

June 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

2.2 years

First QC Date

June 29, 2012

Last Update Submit

January 7, 2016

Conditions

Heart Defects, CongenitalCritical IllnessMental ProcessesChild

Keywords

neurocognitive testingcritical illnessexecutive functionintelligence

Outcome Measures

Primary Outcomes (1)

  • reaction time (RT) and error rates of inhibitory control (Response Organization Objects, ROO) (Amsterdam Neuropsychological Tasks, ANT)

    one testpoint at age of 7 years

Secondary Outcomes (10)

  • reaction time (RT) and error rates of cognitive flexibility (ROO, ANT) and working memory (Memory Search - Objects 2 Keys, ANT)

    one testpoint at age of 7 years

  • Mean RT + standard deviation (SD) of RT on computerized alertness task (Baseline Speed, ANT)

    one testpoint at age of 7 years

  • Number of taps on computerized tapping tasks (ANT)

    one testpoint at age of 7 years

  • IQ measures (Revised Wechsler Preschool and Primary Scale of Intelligence, WPPSI-R)

    one testpoint at age of 7 years

  • Visual-Motor Integration total standard score (VMI)

    one testpoint at age of 7 years

  • +5 more secondary outcomes

Study Arms (2)

CHD group

Seven-year-old children with CHD who were four years old when they participated in Paediatric ICU follow-up study (i.e. first follow-up time point) (Neurocognitive development of children four years after critical illness and treatment with tight glucose control, Clinical Trials # NCT00214916). The children of the CHD-group underwent cardiac surgery as infants (=\<1year).

Control group

Seven-year-old healthy control children who were four years old when they participated in Paediatric ICU follow-up study (i.e. first follow-up time point) (Neurocognitive development of children four years after critical illness and treatment with tight glucose control, Clinical Trials # NCT00214916). These children have never undergone cardiac surgery.

Eligibility Criteria

Age84 Months - 89 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Seven-year-old children with CHD and healthy seven-year-old control children

You may qualify if:

  • Seven-year-old children with CHD and healthy control children who were four years old when they participated in Paediatric ICU follow-up study (i.e. first follow-up time point) (Neurocognitive development of children four years after critical illness and treatment with tight glucose control, Clinical Trials # NCT00214916). The children of the CHD-group underwent cardiac surgery as infants (=\<1year).

You may not qualify if:

  • Genetic syndromes (Down, 22q11del), known to result in neurocognitive impairment
  • IQ \< 70
  • Lack of baseline neurocognitive measurements during first follow-up
  • Date of birth before February 2005

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Intensive Care Medicine

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (2)

  • Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26.

    PMID: 19176240BACKGROUND

  • Sterken C, Lemiere J, Van den Berghe G, Mesotten D. Neurocognitive Development After Pediatric Heart Surgery. Pediatrics. 2016 Jun;137(6):e20154675. doi: 10.1542/peds.2015-4675.

    PMID: 27245833DERIVED

MeSH Terms

Conditions

Heart Defects, CongenitalCritical Illness

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dieter Mesotten, MD PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Dept Intensive Care Medicine

Study Record Dates

First Submitted

June 29, 2012

First Posted

July 3, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

BE(1)