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ISRCTN
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ISRCTN78428828
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ClinicalTrials.gov identifier
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Public title
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Neonatal Insulin Replacement Therapy in Europe
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Scientific title
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Acronym
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NIRTURE
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Serial number at source
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N0544112291 (pilot study reference on NRR)
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Study hypothesis
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It is proposed that relative insulin deficiency in the very low birth weight baby leads to profound catabolism, insulin resistance and hyperglycaemia during the first week of life. High blood glucose levels may lead to osmotic diuresis, intraventricular haemorrhage and increase the risk of sepsis. Insulin deficiency may contribute to slow weight gain and impaired IGF-I generation which could have implications for risk of retinopathy, brain growth and later neurodevelopmental outcomes. It is hypothesised that early intervention with continuous insulin replacement will prevent catabolism and improve glucose control, and could reduce neonatal morbidity and mortality.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Belgium, Netherlands, Spain, United Kingdom
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Disease/condition/study domain
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Nutritional, Metabolic, Endocrine: Hyperglycaemia
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Participants - inclusion criteria
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1. Birth weight <1500 g
2. Requiring intensive care and in whom it is considered appropriate to continue intensive care
3. Less than 24 hours of age
4. Written informed parental consent
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Participants - exclusion criteria
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1. Maternal diabetes including gestational diabetes
2. Babies where the appropriateness of continuing intensive care is being discussed
3. Major congenital anomalies
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Anticipated start date
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25/04/2002
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Anticipated end date
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01/01/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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500
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Interventions
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Intervention: Insulin aspart (NovoNordisk) for intravenous injection. Insulin will be given intravenously at a fixed rate of 0.05 u/kg/hour. It will be prepared as a standard strength solution of 25 units/kg insulin aspart in 50 ml of 0.9% sodium chloride to run at 0.1 ml/hour, equivalent to 0.05 u/kg/hour.
The control intervention will be standard neonatal care.
All babies will be monitored using the Minimed continuous glucose monitoring system (CGMS) for 7 completed days.
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Primary outcome measure(s)
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Death on or before expected date of delivery.
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Secondary outcome measure(s)
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1. Episodes of sepsis in the first 2 weeks
2. Growth
3. Incidence of necrotizing enterocolitis
4. Retinopathy of prematurity
5. Incidence of intracranial haemorrhage
6. Chronic lung disease
7. Death within and including the first 28 days after delivery
8. Days of Neonatal Intensive Care
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Sources of funding
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Medtronic and Novonordisk
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Trial website
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Publications
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Protocol in http://www.ncbi.nlm.nih.gov/pubmed/17692117
Results in http://www.ncbi.nlm.nih.gov/pubmed/18971490
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Contact name
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Prof
David B
Dunger
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Address
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Box No 116
University Dept of Paediatrics
Addenbrooke's NHS Trust
Hills Road
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Tel
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+44 (0)1223 336886
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Fax
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+44 (0)1223 336996
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Email
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dbd25@cam.ac.uk
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Sponsor
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Cambridge University Hospitals NHS Foundation Trust (UK)
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Address
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R&D Department
Box 146
Hills Road
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Tel
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+44 (0)1223 596377
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Email
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sabine.klager@addenbrookes.nhs.uk
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Sponsor website:
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http://www.addenbrookes.nhs.uk
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Date applied
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30/09/2004
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Last edited
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17/11/2008
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Date ISRCTN assigned
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30/09/2004
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