What safety data are needed for a medication to treat gastroesophageal reflux in premature infants? In children younger than 1 year of age? How to design a long-term safety registry for children?
Blumer
Jeffrey L
JL
Heyman
Melvin B
MB
Vandenplas
Yvan
Y
Ward
Robert M
RM
D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000188:drug therapy*; D010372:Pediatrics / Q000592:standards*; D012042:Registries; D012449:Safety; D016896:Treatment Outcome