title: A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe).
abstract: BACKGROUND
  Studies in adult intensive care have highlighted the importance of insulin and improved glucose control on survival, with 32% reduction in mortality, 22% reduction in intensive care stay and halving of the incidence of bacteraemia. Very low birth weight infants requiring intensive care also have relative insulin deficiency often leading to hyperglycaemia during the first week of life. The physiological influences on insulin secretion and sensitivity, and the potential importance of glucose control at this time are not well established. However there is increasing evidence that the early postnatal period is critical for pancreatic development. At this time a complex set of signals appears to influence pancreatic development and beta cell survival. This has implications both in terms of acute glucose control but also relative insulin deficiency is likely to play a role in poor postnatal growth, which has been associated with later motor and cognitive impairment, and fewer beta cells are linked to risk of type 2 diabetes later in life.
  
  
  METHODS
  A multi-centre, randomised controlled trial of early insulin replacement in very low birth weight babies (VLBW, birth weight < 1500 g). 500 infants will be recruited from 10 centres in the UK and Europe. Babies will be randomised to receive a continuous insulin infusion (0.05 units/kg/h) or to receive standard neonatal care from the first day of life and for the next 7 days. If blood glucose (BG) levels fall infants will receive 20% dextrose titrated to maintain normoglycaemia (4-8 mmol/l). If BG is consistently above 10 mmol/l babies will receive standard treatment with additional insulin infusion. The primary end point will be mortality on or before expected date of delivery, secondary end points will be markers of morbidity and include episodes of sepsis, severity of retinopathy, chronic lung disease and growth.
authors: Department of Paediatrics, University of Cambridge, Addenbrooke's Hospital NHS Trust, Hills Road, Cambridge, CB2 2QQ, UK. kb274@cam.ac.uk
authors: Kathryn
authors: K
authors: Beardsall
authors: Sophie
authors: S
authors: Vanhaesebrouck
authors: Amanda L
authors: AL
authors: Ogilvy-Stuart
authors: Jag S
authors: JS
authors: Ahluwalia
authors: Christine
authors: C
authors: Vanhole
authors: Christopher
authors: C
authors: Palmer
authors: Paula
authors: P
authors: Midgley
authors: Mike
authors: M
authors: Thompson
authors: Luc
authors: L
authors: Cornette
authors: Mirjam
authors: M
authors: Weissenbruch
authors: Marta
authors: M
authors: Thio
authors: Francis
authors: F
authors: de Zegher
authors: David
authors: D
authors: Dunger
mesh_terms: D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D004334:Drug Administration Schedule; D016903:Drug Monitoring / Q000379:methods; D005500:Follow-Up Studies; D005947:Glucose / Q000627:therapeutic use; D006801:Humans; D006943:Hyperglycemia / Q000188:drug therapy* / Q000378:metabolism; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D007262:Infusions, Intravenous; D007328:Insulin / Q000172:deficiency / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D005947:Glucose
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