Subject(s)
External Fixators , Mandible/surgery , Osteogenesis, Distraction/instrumentation , Protective Devices , Adolescent , Arm , Cerebral Palsy/complications , Equipment Design , Equipment Failure , Humans , Male , Osteogenesis, Distraction/methods , Reoperation , Respiratory Aspiration/surgery , Sleep Apnea, Obstructive/surgeryABSTRACT
OBJECTIVES: High-dose recombinant erythropoietin is neuroprotective in animal models of neonatal brain injury. Extremely low birth weight infants are at high risk for brain injury and neurodevelopmental problems and might benefit from recombinant erythropoietin. We designed a phase I/II trial to test the safety and determine the pharmacokinetics of high-dose recombinant erythropoietin in extremely low birth weight infants. METHODS: In a prospective, dose-escalation, open-label trial, we compared 30 infants who were treated with high-dose recombinant erythropoietin with 30 concurrent control subjects. Eligible infants were <24 hours old, Subject(s)
Brain Diseases/prevention & control
, Developmental Disabilities/drug therapy
, Erythropoietin/administration & dosage
, Erythropoietin/pharmacokinetics
, Infant, Premature, Diseases/drug therapy
, Analysis of Variance
, Brain Diseases/drug therapy
, Brain Diseases/mortality
, Developmental Disabilities/mortality
, Developmental Disabilities/prevention & control
, Dose-Response Relationship, Drug
, Drug Administration Schedule
, Female
, Follow-Up Studies
, Gestational Age
, Humans
, Infant, Extremely Low Birth Weight
, Infant, Newborn
, Infant, Premature, Diseases/mortality
, Infant, Premature, Diseases/prevention & control
, Infusions, Intravenous
, Male
, Prospective Studies
, Recombinant Proteins
, Reference Values
, Risk Assessment
, Single-Blind Method
, Survival Analysis
, Treatment Outcome
