Suchergebnisse

Objective This study aims to determine the association between hyperglycemia, insulin therapy, and severe retinopathy of prematurity (ROP) in extremely low-birth-weight (ELBW) infants. Study Design In this retrospective database study, we included all ELBW infants who were 180 mg/dL. Covariates were GA, small for GA status, discharge year, sex, Apgar score at 5 minutes, mechanical ventilation, oxygen use, bacteremia, and postnatal steroid exposure. We defined severe ROP as ROP requiring bevacizumab, cryotherapy, laser therapy, or vitrectomy. Sensitivity analysis using BG > 150 mg/dL and > 200 mg/dL was performed. Results A total of 24,548 infants were included; 2,547 (10%) had severe ROP. Hyperglycemia alone was not associated with severe ROP (odds ratio [OR], 0.88; 95% confidence interval [CI], 0.66-1.17). Hyperglycemia and insulin use were not associated with severe ROP (OR, 1.43; 95% CI, 0.91-2.23). BG > 150 mg/dL and insulin use were associated with severe ROP (OR, 1.34; 95% CI, 1.02-1.76). Conclusions Hyperglycemia alone was not associated with severe ROP in ELBW infants. However, we did observe a possible trend between the use of insulin and severe ROP. ; National Center for Advancing Translational Sciences of the National Institutes of Health (NIH) ; U.S. government ; National Institute of Child Health and Human Development ; NIH ; National Center for Advancing Translational Sciences of the NIH ; U.S. Food and Drug Administration ; Cempra Pharmaceuticals ; Duke Univ, Dept Pediat, Sch Med, Durham, NC 27706 USA ; Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA ; KK Womens & Childrens Hosp, Childrens Intens Care Unit, Singapore, Singapore ; Univ Fed Sao Paulo, Ecola Paulista Med, Div Neonatal Med, Sao Paulo, Brazil ; Univ N Carolina, Dept Pediat, Chapel Hill, NC USA ; MEDNAX Inc, Pediat Med Grp, Jacksonville, FL USA ; Univ Fed Sao Paulo, Ecola Paulista Med, Div Neonatal Med, Sao Paulo, Brazil ; NIH: UL1TR001117 ; U.S. government: HHSN267200700051C ; National Institute of Child Health and Human Development: K23HD068497 ; National Institute of Child Health and Human Development: HHSN275201000003I ; National Institute of Child Health and Human Development: 1R01-HD081044-01 ; National Center for Advancing Translational Sciences of the NIH: UL1TR001117 ; U.S. Food and Drug Administration: 1R18-FD005292-01 ; Cempra Pharmaceuticals: HHS0100201300009C ; Web of Science

Until approximately 15 years ago, sponsors rarely included children in the development of therapeutics. US and European legislation has resulted in an increase in the number of pediatric trials and specific label changes and dosing recommendations, although infants remain an understudied group. The lack of clinical trials in children is partly due to specific challenges in conducting trials in this patient population. Therapeutics in special populations, including premature infants, obese children and children receiving extracorporeal life support, are even less studied. National research networks in Europe and the USA are beginning to address some of the gaps in pediatric therapeutics using novel clinical trial designs. Recent innovations in pediatric clinical trial design, including sparse and scavenged sampling, population pharmacokinetic analyses and 'opportunistic' studies, have addressed some of the historical challenges associated with clinical trials in children.