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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

Published online by Cambridge University Press:  17 May 2019

Constanze Pfitzer Open the ORCID record for Constanze Pfitzer [Opens in a new window] ,
Hannah Ferentzi ,
Lisa-Maria Rosenthal ,
Peter Kramer ,
Felix Berger  and
Katharina R. L. Schmitt
Constanze Pfitzer*
Affiliation:
Department of Congenital Heart Disease – Pediatric Cardiology, German Heart Center Berlin, Berlin, Germany Berlin Institute of Health (BIH), Berlin, Germany DZHK (German Center for Cardiovascular Research), partner site Berlin, Germany
Hannah Ferentzi
Affiliation:
Department of Congenital Heart Disease – Pediatric Cardiology, German Heart Center Berlin, Berlin, Germany
Lisa-Maria Rosenthal
Affiliation:
Department of Congenital Heart Disease – Pediatric Cardiology, German Heart Center Berlin, Berlin, Germany Berlin Institute of Health (BIH), Berlin, Germany
Peter Kramer
Affiliation:
Department of Congenital Heart Disease – Pediatric Cardiology, German Heart Center Berlin, Berlin, Germany
Felix Berger
Affiliation:
Department of Congenital Heart Disease – Pediatric Cardiology, German Heart Center Berlin, Berlin, Germany DZHK (German Center for Cardiovascular Research), partner site Berlin, Germany Department of Pediatric Cardiology, Charité - Universitaetsmedizin Berlin, Berlin, Germany
Katharina R. L. Schmitt
Affiliation:
Department of Congenital Heart Disease – Pediatric Cardiology, German Heart Center Berlin, Berlin, Germany DZHK (German Center for Cardiovascular Research), partner site Berlin, Germany
*
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: [email protected]
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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.

Keywords

CHDchild developmentmotor developmentlanguage developmentcognitive developmentparentingBayley Scales of Infant Development
Type
Original Article
Information
Cardiology in the Young , Volume 29 , Issue 5 , May 2019 , pp. 672 - 678
Copyright
© Cambridge University Press 2019 

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Footnotes

*

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).

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