- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01567579
An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Research suggests that children with congenital heart disease are at higher risk for neurodevelopmental and psychosocial problems. Routine developmental screening and early intervention have been suggested as strategies to identify and ameliorate these problems. The purpose of this study is to describe the developmental trajectory and psychosocial functioning of children referred to the Herma Heart Center Developmental Follow-Up Program for routine developmental assessment.
The specific aims of this project are:
- to summarize the results of developmental screening, quality of life, and family impact in subjects that have been evaluated in the HHC Developmental Follow-Up Program since its inception in 2007,
- to evaluate longitudinal changes in the trajectory of development for subjects that undergo repeated developmental and psychosocial screening,
- to characterize how subjects with congenital heart disease compare to normative data for the instruments utilized and samples of children with other chronic health conditions, and
- to determine what factors predict variability in developmental outcomes i.e. demographic and clinical variables such as gender, race, socioeconomic status, diagnosis, type of surgery, and length of hospitalization among others.
Because our research and the research of others have indicated that children with Congenital Heart Disease (CHD) are at higher risk for neurodevelopmental and psychosocial problems, the Herma Heart Center Developmental Follow-Up Program was created in 2007. All infants who have open-heart surgery within the first 30 days of life, and all children under the age of 3 years who have a cyanotic lesion are referred to the clinic.
This study will utilize both retrospective chart review and prospective collection of data from new subjects entering the program.
No additional procedures are required to participate in the research study. Participation in the research study involves granting permission for the research team to systematically analyze the data obtained during the HHC Developmental Follow-Up Program clinic visits that a child participates in and to aggregate these data with all subjects that have received these follow-up assessments.
A sample size of 1000 subjects is needed to ensure adequate power to detect medium effect sizes for the multiple outcome measures that are proposed (assuming p = .05 and power = .80). Therefore, recruitment for the study will continue until a sample size of 1000 subjects is reached. Estimated recruitment duration is 7 years.
There are no anticipated risks related to participation in this study.
Descriptive analyses will be conducted to summarize characteristics of the sample and to determine the frequency of developmental/behavioral/emotional problems among children in the present sample. Correlation and regression analyses will be conducted to examine the relationships among demographic, clinical, and outcome variables. For children with multiple visits, longitudinal changes and the pattern of developmental trajectory for children with congenital heart disease will be examined.
Results may point to possible areas for intervention to improve child and family psychosocial outcomes.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Children's Hospital of Wisconsin
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Referred to the Herma Heart Center (HHC)Developmental Follow-Up Clinic for assessment.
Exclusion Criteria:
- Non-English and Non-Spanish speaking families
- Children with extremely complex co-morbidities
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Solo caso
- Prospettive temporali: Prospettiva
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Bayley Scales of Infant and Toddler Development Third Edition
Lasso di tempo: every 6 months
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test of developmental skills
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every 6 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Cheryl L Brosig, PhD, Medical College of Wisconsin
- Investigatore principale: Laurel M Bear, MD, Medical College of Wisconsin
Pubblicazioni e link utili
Pubblicazioni generali
- Soto CB, Olude O, Hoffmann RG, Bear L, Chin A, Dasgupta M, Mussatto K. Implementation of a routine developmental follow-up program for children with congenital heart disease: early results. Congenit Heart Dis. 2011 Sep-Oct;6(5):451-60. doi: 10.1111/j.1747-0803.2011.00546.x. Epub 2011 Jul 1.
- Mussatto KA, Hoffmann RG, Hoffman GM, Tweddell JS, Bear L, Cao Y, Brosig C. Risk and prevalence of developmental delay in young children with congenital heart disease. Pediatrics. 2014 Mar;133(3):e570-7. doi: 10.1542/peds.2013-2309. Epub 2014 Feb 2.
- Mussatto KA, Hoffmann R, Hoffman G, Tweddell JS, Bear L, Cao Y, Tanem J, Brosig C. Risk Factors for Abnormal Developmental Trajectories in Young Children With Congenital Heart Disease. Circulation. 2015 Aug 25;132(8):755-61. doi: 10.1161/CIRCULATIONAHA.114.014521.
- Brosig CL, Bear L, Allen S, Hoffmann RG, Pan A, Frommelt M, Mussatto KA. Preschool Neurodevelopmental Outcomes in Children with Congenital Heart Disease. J Pediatr. 2017 Apr;183:80-86.e1. doi: 10.1016/j.jpeds.2016.12.044. Epub 2017 Jan 9.
- Brosig CL, Bear L, Allen S, Simpson P, Zhang L, Frommelt M, Mussatto KA. Neurodevelopmental outcomes at 2 and 4 years in children with congenital heart disease. Congenit Heart Dis. 2018 Sep;13(5):700-705. doi: 10.1111/chd.12632. Epub 2018 Sep 6.
- Jilek E, Shields A, Zhang L, Simpson P, Bear L, Martins SA, Mussatto KA, Brosig CL. Predictors of behavioural and emotional outcomes in toddlers with congenital heart disease. Cardiol Young. 2022 Aug;32(8):1216-1221. doi: 10.1017/S1047951121003942. Epub 2021 Sep 22.
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CHW 09/98, GC 896
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Difetti cardiaci congeniti
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Region SkaneIscrizione su invitoInsufficienza cardiaca Classe II della New York Heart Association (NYHA). | Insufficienza cardiaca Classe III della New York Heart Association (NYHA).Svezia
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Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... e altri collaboratoriNon ancora reclutamentoInsufficienza cardiaca, sistolica | Insufficienza cardiaca con frazione di eiezione ridotta | Scompenso cardiaco Classe IV della New York Heart Association | Scompenso cardiaco Classe III della New York Heart AssociationPolonia
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University of WashingtonAmerican Heart AssociationCompletatoInsufficienza cardiaca, congestizia | Alterazione mitocondriale | Scompenso cardiaco Classe IV della New York Heart AssociationStati Uniti