试验药物NT100的NT-04临床试验有限,虽然地理位置不同,研究人群。加强潜在出生缺陷识别,对婴儿进行了照相形态学检查,并审查了产前和产后医疗记录。
开发了标准化的摄影视图:全身(俯卧和仰卧),脸,两个配置文件,背侧和腹侧的手和脚,生殖器,和胎记/皮肤损伤。对专业摄影师进行了鉴定和培训。照片是在受试者家中生活的第一个月拍摄的,并上传到安全的电子在线照片查看器。评估遗传学家以电子方式访问了照片并提交了评估。
40名受试者有39个可评估的结果(55名婴儿)。招募了十二名摄影师,其中10人与多个科目一起工作。对38例妊娠结局进行了照相形态学评估。由于明显的协议错误,只有一个婴儿丢失了照片。四个婴儿穿着尿布拍照。
标准化的照片效果很好。优点包括:一名临床医生评估所有婴儿,这些照片可以根据需要反复审查,和较小的畸形被更统一地识别。困难是:识别当地摄影师并提供培训和培训材料。没有重新拍摄或获取新照片的协议,研究同意书不包括发布照片的许可。这是一项成功的婴儿摄影评估试点研究,可在临床试验中检测先天性异常。
The NT-04 clinical
trial of investigational medication NT100 had a limited, though geographically diverse,
study population. To enhance potential birth defect identification, photographic
dysmorphology exam of infants was performed along with review of prenatal and postnatal medical records.
Standardized photographic views were developed: full body (prone and supine), face, both profiles, dorsal and ventral hands and feet, genitalia, and birthmarks/skin lesions. Professional photographers were identified and trained. Photos were taken in the first month of life at the subject\'s home and uploaded to a secure electronic online photo viewer. The evaluating geneticist accessed the photos electronically and submitted an evaluation.
Forty subjects had 39 evaluable outcomes (55 babies). Twelve photographers were recruited, 10 of whom worked with multiple subjects. Photographic
dysmorphology evaluation was done on 38 pregnancy outcomes. Only one baby had missing photos due to an apparent protocol error. Four babies were photographed with diaper on.
The standardized photographs worked well. Advantages include: a single clinician evaluating all infants, the photographs could be reviewed repeatedly as needed, and minor malformations were more uniformly identified. Difficulties were: identifying local photographers and supplying training and training materials. There was no protocol for retaking or obtaining new photos and the study consent form did not include permission to publish the photographs. This was a successful pilot study of infant photographic assessment to detect congenital anomalies in a clinical
trial.