Ferentzi Hannah, Pfitzer Constanze, Rosenthal Lisa-Maria, Berger Felix, Schmitt Katharina R L
Department of Congenital Heart Disease-Paediatric Cardiology, Deutsches Herzzentrum Berlin, Berlin, Germany.
Unit for Psychosomatic Medicine, Deutsches Herzzentrum Berlin, Berlin, Germany.
BMJ Open. 2017 Dec 28;7(12):e018966. doi: 10.1136/bmjopen-2017-018966.
Congenital heart disease (CHD) is the most common birth defect. Studies on the development of children with CHD point towards deficits in motoric, cognitive and language development. However, most studies are cross-sectional and there is a gap in the knowledge concerning developmental trajectories, risk and protective factors and a lack of research concerning environmental predictors. Specifically, no studies have so far considered the importance of early caregiving experiences and child temperament for the development of children with CHD.
In a single-centre prospective cohort study, cognitive, motoric and language development of 180 children after corrective surgery for a simple transposition of the great arteries (TGA), tetralogy of Fallot (TOF) or ventricular septal defect (VSD) will be assessed at ages 12, 24 and 36 months with the Bayley Scales of Infant Development 3rd Edition (BSID-III). At age 12 months, a free-play video observation will be conducted to investigate the relationship between primary caregiver and child, and child temperament will be assessed with the Infant Behavior Questionnaire-Revised Short Version. Medical information will be obtained from patient records and demographic information via questionnaires.
Frequency and severity of developmental delays will be reported descriptively. Differences between groups (TGA, TOF, VSD) will be subjected to repeated-measures analysis across time points. Multiple regressions will be applied for the analysis of predictors at each time point. For the analysis of differential developmental trajectories, mixed-model analysis will be applied.
The study has been approved by the local medical ethics committee. Written informed consent will be obtained from all participants. Parents have the option to be debriefed about BSID-III results after each assessment and about the study results after project completion. Results will be disseminated in peer-reviewed journals and presented at conferences.
DRKS00011006; Pre-results.
先天性心脏病（CHD）是最常见的出生缺陷。对患有CHD儿童发育情况的研究表明，他们在运动、认知和语言发展方面存在缺陷。然而，大多数研究都是横断面研究，在发育轨迹、风险和保护因素方面的知识存在空白，并且缺乏关于环境预测因素的研究。具体而言，到目前为止，尚无研究考虑早期照料经历和儿童气质对患有CHD儿童发育的重要性。
在一项单中心前瞻性队列研究中，将使用贝利婴幼儿发展量表第三版（BSID-III）在12、24和36个月时评估180名接受了大动脉转位（TGA）、法洛四联症（TOF）或室间隔缺损（VSD）矫正手术儿童的认知、运动和语言发展情况。在12个月时，将进行一次自由玩耍视频观察，以研究主要照料者与儿童之间的关系，并使用修订版婴儿行为问卷简版评估儿童气质。将从患者记录中获取医疗信息，并通过问卷获取人口统计学信息。
将以描述性方式报告发育迟缓的频率和严重程度。将对各时间点的组间差异（TGA、TOF、VSD）进行重复测量分析。将应用多元回归分析每个时间点的预测因素。对于差异发育轨迹的分析，将应用混合模型分析。
该研究已获得当地医学伦理委员会的批准。将从所有参与者处获得书面知情同意书。家长可以选择在每次评估后了解BSID-III结果，并在项目完成后了解研究结果。研究结果将在同行评审期刊上发表，并在会议上展示。
DRKS00011006；预结果。
