Patients with mild CHD abnormalities, e.g., isolated patent ductus arteriosus, atrial/ventricular septal defect, or patent foramen ovale, were excluded.
The other AEs reported in the placebo/no treatment controlled RCTs were usually associated with prematurity (intraventricular haemorrhage, periventricular leucomalacia, necrotising enterocolitis, patent ductus arteriosus and hearing abnormalities) and there were no significant differences between azithromycin and the comparator arms.
Human patients also show abnormalities in the outflow tract ranging from patent ductus arteriosus, mitral or aortic valvular abnormalities to coarctation of the aorta, and ascending aorta aneurysm [ 12– 12].
Patent urachus is a rare congenital abnormality.
Other proposed mechanisms include infective endocarditis, left atrial thrombosis and myxoma, aortic arch atheroma, mitral annulus calcification, left atrial appendage thrombus, valvular abnormalities, papillary fibroelastoma, and patent foramen ovale [ 6].
Patent Foramen Ovale (PFO), a congenital cardiac abnormality where the left and right atria of the heart are connected, is highly prevalent (25%-30%) in the general population [ 1].
Patients who only had mild CHD abnormalities (i.e. isolated patent ductus arteriosus and patent foramen ovale) or were affected only by arrhythmia or cardiomyopathy were excluded from this study.
Skeletal abnormalities (growth retardation, delayed tooth eruption, patent cranial sutures, epiphyseal dysgenesis) and intestinal dysmotility in human RTHα are recapitulated in mutant TRα1 mutant mouse models [11,30].
Abnormalities were noted for eight babies in the Prolutex group (including club foot, Epstein abnormality, heart murmur, hydronephrosis, intraventricular haemorrhage and patent ductus arteriosis) and for two babies in the Endometrin group (Down's syndrome, neonatal tooth).
Failed obliteration of the urachus can lead to various abnormalities: urachal cyst, urachal diverticulum, sinus or patent urachus - the most common type.
There are reports in sheep of ventricular septal defects [ 12], tetralogy of Fallot [ 13], patent ductus arteriosus [ 14] and other rarer congenital cardiac abnormalities [ 12, 13] which were all identified at post-mortem examination.
