Hostname: page-component-848d4c4894-nr4z6 Total loading time: 0 Render date: 2024-06-07T19:34:54.693Z Has data issue: false hasContentIssue false
  • English
  • Français

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: pfitzer@dhzb.de
Get access Rights & Permissions [Opens in a new window]

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 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

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).

References

Wren, C, Richmond, S, Donaldson, L. Temporal variability in birth prevalence of cardiovascular malformations. Heart 2000; 83: 414–419.CrossRefGoogle ScholarPubMed
Hoffman, JI, Kaplan, S. The incidence of congenital heart disease. J Am Coll Cardiol 2002; 39: 1890–1900.CrossRefGoogle ScholarPubMed
Engel, MS,Kochilas, LK. Pulse oximetry screening: a review of diagnosing critical congenital heart disease in newborns. Med Devices (Auckl) 2016; 9: 199–203.Google ScholarPubMed
Verdurmen, KM, Eijsvoogel, NB, Lempersz, C, et al. A systematic review of prenatal screening for congenital heart disease by fetal electrocardiography. Int J Gynaecol Obstet 2016; 135: 129–134.CrossRefGoogle ScholarPubMed
Ohye, RG,Bove, EL. Advances in congenital heart surgery. Curr Opin Pediatr 2001; 13(5): 473–481.CrossRefGoogle ScholarPubMed
Sizarov, A,Boudjemline, Y. Novel materials and devices in the transcatheter management of congenital heart diseases-the future comes slowly (part 1). Arch Cardiovasc Dis 2016; 109: 278–285.CrossRefGoogle Scholar
Holland, BJ, Myers, JA, Woods, CR Jr. Prenatal diagnosis of critical congenital heart disease reduces risk of death from cardiovascular compromise prior to planned neonatal cardiac surgery: a meta-analysis. Ultrasound Obstet Gynecol 2015; 45: 631–638.CrossRefGoogle ScholarPubMed
Khairy, P, Ionescu-Ittu, R, Mackie, AS, Abrahamowicz, M, Pilote, L, Marelli, AJ. Changing mortality in congenital heart disease. J Am Coll Cardiol 2010; 56: 1149–1157.CrossRefGoogle ScholarPubMed
Bouma, BJ,Mulder, BJ. Changing landscape of congenital heart disease. Circ Res 2017; 120: 908–922.CrossRefGoogle ScholarPubMed
Ntiloudi, D, Giannakoulas, G, Parcharidou, D, Panagiotidis, T, Gatzoulis, MA, Karvounis, H. Adult congenital heart disease: a paradigm of epidemiological change. Int J Cardiol 2016; 218: 269–274.CrossRefGoogle ScholarPubMed
Gaynor, JW, Stopp, C, Wypij, D, et al. Neurodevelopmental outcomes after cardiac surgery in infancy. Pediatrics 2015; 135: 816–825.CrossRefGoogle ScholarPubMed
Snookes, SH, Gunn, JK, Eldridge, BJ, et al. A systematic review of motor and cognitive outcomes after early surgery for congenital heart disease. Pediatrics 2010; 125: e818–e827.CrossRefGoogle ScholarPubMed
Gaynor, JW, Gerdes, M, Nord, AS, et al. Is cardiac diagnosis a predictor of neurodevelopmental outcome after cardiac surgery in infancy? J Thorac Cardiovasc Surg 2010; 140: 1230–1237.CrossRefGoogle ScholarPubMed
Hallioglu, O, Gurer, G, Bozlu, G, Karpuz, D, Makharoblidze, K, Okuyaz, C. Evaluation of neurodevelopment using Bayley-III in children with cyanotic or hemodynamically impaired congenital heart disease. Congenit Heart Dis 2015; 10: 537–541.CrossRefGoogle ScholarPubMed
Karsdorp, PA, Everaerd, W, Kindt, M, Mulder, BJ. Psychological and cognitive functioning in children and adolescents with congenital heart disease: a meta-analysis. J Pediatr Psychol 2007; 32: 527–541.CrossRefGoogle ScholarPubMed
Massaro, AN, El-Dib, M, Glass, P, Aly, H. Factors associated with adverse neurodevelopmental outcomes in infants with congenital heart disease. Brain Dev 2008; 30: 437–446.CrossRefGoogle ScholarPubMed
Latal, B. Neurodevelopmental outcomes of the child with congenital heart disease. Clin Perinatol 2016; 43: 173–185.CrossRefGoogle Scholar
McQuillen, PS,Miller, SP. Congenital heart disease and brain development. Ann N Y Acad Sci 2010; 1184: 68–86.CrossRefGoogle ScholarPubMed
Rollins, CK. A mixed bag: Differential influences of oxygenation and perfusion on brain development in congenital heart disease. J Thorac Cardiovasc Surg 2016; 152: 960–961.CrossRefGoogle ScholarPubMed
Impact of operative and postoperative factors on neurodevelopmental outcomes after cardiac operations. Ann Thorac Surg 2016; 102: 843–849.CrossRefGoogle Scholar
Dimitropoulos, A, McQuillen, PS, Sethi, V, et al. Brain injury and development in newborns with critical congenital heart disease. Neurology 2013; 81: 241–248.CrossRefGoogle ScholarPubMed
Hovels-Gurich, HH, Konrad, K, Skorzenski, D, et al. Long-term neurodevelopmental outcome and exercise capacity after corrective surgery for tetralogy of Fallot or ventricular septal defect in infancy. Ann Thorac Surg 2006; 81: 958–966.CrossRefGoogle ScholarPubMed
Hovels-Gurich, HH, Bauer, SB, Schnitker, R, et al. Long-term outcome of speech and language in children after corrective surgery for cyanotic or acyanotic cardiac defects in infancy. Eur J Paediatr Neurol 2008; 12(5): 378–386.CrossRefGoogle ScholarPubMed
Gaynor, JW, Wernovsky, G, Jarvik, GP, et al. Patient characteristics are important determinants of neurodevelopmental outcome at one year of age after neonatal and infant cardiac surgery. J Thorac Cardiovasc Surg 2007; 133: 1344–1353 e1-3.CrossRefGoogle ScholarPubMed
Gupta, P, Wilcox, A, Noel, TR, et al. Characterizing cardiac arrest in children undergoing cardiac surgery: A single-center study. J Thorac Cardiovasc Surg 2017; 153: 450–458 e1.CrossRefGoogle ScholarPubMed
Matos, RI, Watson, RS, Nadkarni, VM, et al. Duration of cardiopulmonary resuscitation and illness category impact survival and neurologic outcomes for in-hospital pediatric cardiac arrests. Circulation, 2013; 127: 442–451.CrossRefGoogle ScholarPubMed
Kramer, P, Miera, O, Berger, F, Schmitt, K. Prognostic value of serum biomarkers of cerebral injury in classifying neurological outcome after paediatric resuscitation. Resuscitation 2018; 122: 113–120.CrossRefGoogle ScholarPubMed
McGrath, E, Wypij, D, Rappaport, LA, Newburger, JW, Bellinger, DC. Prediction of IQ and achievement at age 8 years from neurodevelopmental status at age 1 year in children with D-transposition of the great arteries. Pediatrics 2004; 114: e572–e576.CrossRefGoogle ScholarPubMed
Mussatto, KA, Hoffmann, RG, Hoffman, GM, et al. Risk and prevalence of developmental delay in young children with congenital heart disease. Pediatrics 2014; 133: e570–e577.CrossRefGoogle ScholarPubMed
Bayley, N. Bayley Scales of Infant and Toddler Development: Bayley-III. Deutsche Bearbeitung. San Antonio: Pearson Assessment & Information GmbH, 2006.Google Scholar
Ferentzi, H, Pfitzer, C, Rosenthal, LM, Berger, F, Schmitt, KRL, Kramer, P. Developmental outcome in infants with cardiovascular disease after cardiopulmonary resuscitation: a pilot study. J Clin Psychol Med Settings 2019.CrossRefGoogle Scholar
Ferentzi, H, Pfitzer, C, Rosenthal, LM, Berger, F, Schmitt, KRL. Long-term early development research in congenital heart disease (LEADER-CHD): a study protocol for a prospective cohort observational study investigating the development of children after surgical correction for congenital heart defects during the first 3 years of life. BMJ Open 2017; 7: e018966.CrossRefGoogle ScholarPubMed
Wechsler, D. Wechsler Intelligence Scale for Children, 4th edn. London: Pearson, Psychological Corporation, 2003.Google Scholar
Wechsler, D., Wechsler Intelligence Scale for Children, 5th edn. Bloomington: Pearson, Psychological Corporation, 2014.Google Scholar
Biringen, Z, Easterbrooks, MA. Emotional availability: concept, research, and window on developmental psychopathology. Dev Psychopathol 2012; 24: 1–8.CrossRefGoogle ScholarPubMed
Head, ML, Holman, L, Lanfear, R, Kahn, AT, Jennions, MD. The extent and consequences of p-hacking in science. PLoS Biol 2015; 13: e1002106.CrossRefGoogle Scholar
Teague, S, Youssef, GJ, Macdonald, JA, et al. Retention strategies in longitudinal cohort studies: a systematic review and meta-analysis. BMC Med Res Methodol 2018; 18: 151.CrossRefGoogle ScholarPubMed
Limperopoulos, C, Majnemer, A, Shevell, MI, Rosenblatt, B, Rohlicek, C, Tchervenkov, C. Neurodevelopmental status of newborns and infants with congenital heart defects before and after open heart surgery. J Pediatr 2000; 137: 638–645.CrossRefGoogle ScholarPubMed
Friedman, L. Commentary: Why we should report results from clinical trial pilot studies. Trials 2013; 14: 14.CrossRefGoogle ScholarPubMed
Leon, AC, Davis, LL, Kraemer, HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res 2011; 45: 626–629.CrossRefGoogle ScholarPubMed