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Neonatal Insulin Replacement Therapy in Europe
DOI 10.1186/ISRCTN78428828
ClinicalTrials.gov identifier
EudraCT number
Public title Neonatal Insulin Replacement Therapy in Europe
Scientific title
Serial number at source N0544112291 (pilot study reference on NRR)
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Belgium, Netherlands, Spain, United Kingdom
Disease/condition/study domain Nutritional, Metabolic, Endocrine: Hyperglycaemia
Participants - inclusion criteria 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
Participants - exclusion criteria 1. Maternal diabetes including gestational diabetes
2. Babies where the appropriateness of continuing intensive care is being discussed
3. Major congenital anomalies
Anticipated start date 25/04/2002
Anticipated end date 01/01/2008
Status of trial Completed
Patient information material
Target number of participants 500
Interventions 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.
Primary outcome measure(s) Death on or before expected date of delivery.
Secondary outcome measure(s) 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
Sources of funding Medtronic and Novonordisk
Trial website
Publications 2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17692117
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18971490
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24518169
Contact name Prof  David B  Dunger
  Address Box No 116
University Dept of Paediatrics
Addenbrooke's NHS Trust
Hills Road
  City/town Cambridge
  Zip/Postcode CB2 2QQ
  Country United Kingdom
  Tel +44 (0)1223 336886
  Fax +44 (0)1223 336996
  Email dbd25@cam.ac.uk
Sponsor Cambridge University Hospitals NHS Foundation Trust (UK)
  Address R&D Department
Box 146
Hills Road
  City/town Cambridge
  Zip/Postcode CB2 2QQ
  Country United Kingdom
  Tel +44 (0)1223 596377
  Email sabine.klager@addenbrookes.nhs.uk
  Sponsor website: http://www.addenbrookes.nhs.uk
Date applied 30/09/2004
Last edited 03/06/2014
Date ISRCTN assigned 30/09/2004
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