A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe)
<p>Abstract</p> <p>Background</p> <p>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. V...
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BMC
2007-08-01
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Series: | BMC Pediatrics |
Online Access: | http://www.biomedcentral.com/1471-2431/7/29 |
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author | Cornette Luc Thompson Mike Midgley Paula Palmer Christopher Vanhole Christine Ahluwalia Jag S Ogilvy-Stuart Amanda L Vanhaesebrouck Sophie Beardsall Kathryn Weissenbruch Mirjam Thio Marta de Zegher Francis Dunger David |
author_facet | Cornette Luc Thompson Mike Midgley Paula Palmer Christopher Vanhole Christine Ahluwalia Jag S Ogilvy-Stuart Amanda L Vanhaesebrouck Sophie Beardsall Kathryn Weissenbruch Mirjam Thio Marta de Zegher Francis Dunger David |
author_sort | Cornette Luc |
collection | DOAJ |
description | <p>Abstract</p> <p>Background</p> <p>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 β 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 β cells are linked to risk of type 2 diabetes later in life.</p> <p>Methods</p> <p>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.</p> <p>Trial Registration</p> <p>Current Controlled Trials ISRCTN78428828. EUDRACT Number 2004-002170-34</p> |
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institution | Directory Open Access Journal |
issn | 1471-2431 |
language | English |
last_indexed | 2024-04-12T23:55:32Z |
publishDate | 2007-08-01 |
publisher | BMC |
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series | BMC Pediatrics |
spelling | doaj.art-282a696d67cc4c7ebd0baf3318ba381d2022-12-22T03:11:30ZengBMCBMC Pediatrics1471-24312007-08-01712910.1186/1471-2431-7-29A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe)Cornette LucThompson MikeMidgley PaulaPalmer ChristopherVanhole ChristineAhluwalia Jag SOgilvy-Stuart Amanda LVanhaesebrouck SophieBeardsall KathrynWeissenbruch MirjamThio Martade Zegher FrancisDunger David<p>Abstract</p> <p>Background</p> <p>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 β 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 β cells are linked to risk of type 2 diabetes later in life.</p> <p>Methods</p> <p>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.</p> <p>Trial Registration</p> <p>Current Controlled Trials ISRCTN78428828. EUDRACT Number 2004-002170-34</p>http://www.biomedcentral.com/1471-2431/7/29 |
spellingShingle | Cornette Luc Thompson Mike Midgley Paula Palmer Christopher Vanhole Christine Ahluwalia Jag S Ogilvy-Stuart Amanda L Vanhaesebrouck Sophie Beardsall Kathryn Weissenbruch Mirjam Thio Marta de Zegher Francis Dunger David A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe) BMC Pediatrics |
title | A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe) |
title_full | A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe) |
title_fullStr | A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe) |
title_full_unstemmed | A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe) |
title_short | A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe) |
title_sort | randomised controlled trial of early insulin therapy in very low birth weight infants nirture neonatal insulin replacement therapy in europe |
url | http://www.biomedcentral.com/1471-2431/7/29 |
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