Defect evaluation by infant photographs in a multicenter pharmaceutical clinical trial.
OBJECT
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
['Scheuerle|Angela E|AE|0000-0002-9025-3276', 'Kwon|Paul|P|', 'Joing|Mark|M|']
D016022:Case-Control Studies D002986:Clinical Trials as Topic D000013:Congenital Abnormalities D064420:Drug-Related Side Effects and Adverse Reactions D005260:Female D006801:Humans D007231:Infant, Newborn D008297:Male D010781:Photography D010865:Pilot Projects D011247:Pregnancy D011297:Prenatal Exposure Delayed Effects
photograph dysmorphology photography pregnancy registry prenatal exposure