Département d'Orthopédie Dento-Faciale, Pôle de médecine et chirurgie buccodentaires, Hospices civils, Place de l'Hôpital 1, Strasbourg 67000, France.
BMC Pediatr. 2012 Jun 8;12:65. doi: 10.1186/1471-2431-12-65.
The birth of a child with a cleft lip, whether or not in association with a cleft palate, is a traumatic event for parents. This prospective, multidisciplinary and multi-centre study aims to explore the perceptions and feelings of parents in the year following the birth of their child, and to analyse parent-child relationships. Four inclusion centres have been selected, differing as to the date of the first surgical intervention, between birth and six months. The aim is to compare results, also distinguishing the subgroups of parents who were given the diagnosis in utero and those who were not.
METHODS/DESIGN: The main hypothesis is that the longer the time-lapse before the first surgical intervention, the more likely are the psychological perceptions of the parents to affect the harmonious development of their child. Parents and children are seen twice, when the child is 4 months (T0) and when the child is one year old (T1). At these two times, the psychological state of the child and his/her relational abilities are assessed by a specially trained professional, and self-administered questionnaires measuring factors liable to affect child-parent relationships are issued to the parents. The Alarme Détresse BéBé score for the child and the Parenting Stress Index score for the parents, measured when the child reaches one year, will be used as the main criteria to compare children with early surgery to children with late surgery, and those where the diagnosis was obtained prior to birth with those receiving it at birth.
The mental and psychological dimensions relating to the abnormality and its correction will be analysed for the parents (the importance of prenatal diagnosis, relational development with the child, self-image, quality of life) and also, for the first time, for the child (distress, withdrawal). In an ethical perspective, the different time lapses until surgery in the different protocols and their effects will be analysed, so as to serve as a reference for improving the quality of information during the waiting period, and the quality of support provided for parents and children by the healthcare team before the first surgical intervention.
ClinicalTrials.gov Identifier: NCT00993993.
唇裂患儿的出生，无论是否伴有腭裂，对父母来说都是一个创伤性事件。本前瞻性、多学科、多中心研究旨在探讨患儿出生后一年内父母的认知和感受，并分析亲子关系。选择了四个纳入中心，根据首次手术干预的时间不同（出生至 6 个月）进行分组。目的是比较结果，并区分在宫内诊断和不在宫内诊断的父母亚组。
方法/设计：主要假设是首次手术干预前的时间间隔越长，父母的心理认知越有可能影响孩子的和谐发展。在孩子 4 个月（T0）和 1 岁（T1）时，两次观察父母和孩子。此时，由专门培训的专业人员评估孩子的心理状态及其关系能力，并向父母发放自我评估问卷，以测量可能影响亲子关系的因素。将在孩子 1 岁时测量的孩子的 Alarme Détresse BéBé 评分和父母的 Parenting Stress Index 评分作为主要标准，比较早期手术和晚期手术的孩子、产前诊断和出生时诊断的孩子。
将分析父母（产前诊断的重要性、与孩子的关系发展、自我形象、生活质量）和孩子（痛苦、退缩）的异常及其矫正的心理和心理维度。从伦理角度出发，将分析不同方案中手术前的不同时间间隔及其影响，以便为改善等待期的信息质量以及医疗团队在首次手术干预前为父母和孩子提供的支持质量提供参考。
ClinicalTrials.gov 标识符：NCT00993993。
