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First steps to a clinical research unit for developmental research in paediatric cardiology: conception and progress of the LEADER project (Long Term Early Development Research) in CHD

  • Constanze Pfitzer (a1) (a2) (a3), Hannah Ferentzi (a1), Lisa-Maria Rosenthal (a1) (a2), Peter Kramer (a1), Felix Berger (a1) (a3) (a4) and Katharina R. L. Schmitt (a1) (a3)...

Abstract

Objective:

We developed the Long-term Early Development Research (LEADER) project to investigate the development of children with CHD and/or after cardiopulmonary resuscitation. Both populations are at risk for delays in motor, cognitive, and language development. However, few studies to date have investigated the longitudinal development in these children.

Methods:

To establish a clinical research unit, we planned three studies: a cross-sectional study in children after cardiopulmonary resuscitation (LEADER-REA Pilot Study), a longitudinal study in children after cardiopulmonary resuscitation, with a focus on evaluating various biomarkers as predictors for developmental outcome (LEADER-CPR study), and a longitudinal study in children with ventricular septal defect, tetralogy of Fallot, or transposition of the great arteries after cardiac surgery (LEADER-CHD study).

Results:

Implementation of all three LEADER studies was successful and study protocols were conducted as planned. Findings from the LEADER-REA Pilot study have been recently published and data collection for both prospective trials is ongoing. Descriptive analysis of the first 20 assessments of the LEADER-CHD study showed no severe deficits in overall cognitive, motor, and language developments in the children.

Conclusions:

Children with CHD and/or after cardiopulmonary resuscitation are at risk for developmental delay. Therefore, a detailed developmental assessment is necessary as a pre-requisite for individual developmental support. Our LEADER project has been shown to be feasible in a clinical setting and is the first step towards the establishment of a clinical research unit in our clinic with a focus on longitudinal research.

Copyright

Corresponding author

Author for correspondence: Constanze Pfitzer, MD, Department of Congenital Heart Disease – Pediatric Cardiology, Deutsches Herzzentrum Berlin, Augustenburger Platz 13353 Berlin, Germany. Tel: +49 30 4593 2849; Fax: +49 30 4593 2900; E-mail: pfitzer@dhzb.de

Footnotes

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The authors Constanze Pfitzer and Hannah Ferentzi both contributed equally to this publication.

The LEADER project was registered with the German Clinical Trials Register (http://www.drks.de) (DRKS-ID: DRKS00013639 and DRKS00011006).

Footnotes

References

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Keywords

First steps to a clinical research unit for developmental research in paediatric cardiology: conception and progress of the LEADER project (Long Term Early Development Research) in CHD

  • Constanze Pfitzer (a1) (a2) (a3), Hannah Ferentzi (a1), Lisa-Maria Rosenthal (a1) (a2), Peter Kramer (a1), Felix Berger (a1) (a3) (a4) and Katharina R. L. Schmitt (a1) (a3)...

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