Pharmacokinetics and Breast Milk Transfer to Infants of Subcutaneous Extended-Release Buprenorphine for the Treatment of Individuals with Opioid Use Disorder.

Abnormal glycemic control is noted in approximately 10% of pregnancies and is increasing with the rise in obesity and type 2 diabetes. This is largely because of gestational diabetes diagnosed during the second trimester of pregnancy than preexisting diabetes. Recent reported rate of gestational diabetes in the United States is as high as 9.2%. Periconceptional poor control of diabetes among women with type 1 diabetes is also associated with major birth defects in 5 to 10% of pregnancies. Infants of diabetic mothers (IDMs) undergo immediate and persistent aerodigestive consequences following birth. Furthermore, feeding difficulties are a major problem occurring in approximately 37% of IDMs and are a key reason for prolonged hospital stay and parent–infant separation. The pharyngoesophageal motility mechanisms during resting state and upon provocation may play a role for these feeding difficulties; however, precise mechanisms are unclear. Clarification of the underlying pathophysiological mechanisms of pharyngoesophageal motility reflexes could help us devise better objective evidence-based management strategies and personalized feeding therapies aimed at the prevention and treatment of chronic feeding disorders in IDMs. The objective of thisstudy was to test thehypothesis that dysphagic infants with IDM diagnosis have distinct pharyngoesophageal peristaltic characteristics compared with healthy controls. The study was conducted at Nationwide Children’s Hospital, a level 4 tertiary care all-referral neonatal intensive care unit (NICU), in Columbus, Ohio. Twenty dysphagic IDMs who were referred for gastrostomy evaluation at the Neonatal and Infant Feeding Disorders Program were included. These infants were compared with 10 healthy control infants who had independent oral feeding skills and have participated in our maturational study protocols. These controls were feeding and thriving appropriately during the hospital course, and none of these infants had any genetic or birth defects. The studies were performed after obtaining written, informed consent from parent(s) and approval by the Institutional Review Board of Nationwide Children’s Hospital. Subject safety was monitored during and after the study.