Contact information
Type
Scientific
Primary contact
Prof David B Dunger
ORCID ID
Contact details
Box No 116
University Dept of Paediatrics
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 336886
dbd25@cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0544112291 (pilot study reference on NRR)
Study information
Scientific title
Acronym
NIRTURE
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Hyperglycaemia
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Insulin
Primary outcome measure
Death on or before expected date of delivery.
Secondary outcome measures
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
Overall trial start date
25/04/2002
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
500
Participant exclusion criteria
1. Maternal diabetes including gestational diabetes
2. Babies where the appropriateness of continuing intensive care is being discussed
3. Major congenital anomalies
Recruitment start date
25/04/2002
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Belgium, Netherlands, Spain, United Kingdom
Trial participating centre
Box No 116
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospitals NHS Foundation Trust (UK)
Sponsor details
R&D Department
Box 146
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 596377
sabine.klager@addenbrookes.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Medtronic and Novonordisk
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Results
Beardsall K, Vanhaesebrouck S, Ogilvy-Stuart AL, Vanhole C, Palmer CR, van Weissenbruch M, Midgley P, Thompson M, Thio M, Cornette L, Ossuetta I, Iglesias I, Theyskens C, de Jong M, Ahluwalia JS, de Zegher F, Dunger DB, Early insulin therapy in very-low-birth-weight infants., N. Engl. J. Med., 2008, 359, 18, 1873-1884, doi: 10.1056/NEJMoa0803725.
-
Results
Beardsall K, Vanhaesebrouck S, Frystyk J, Ogilvy-Stuart AL, Vanhole C, van Weissenbruch M, Midgley P, Thio M, Cornette L, Gill B, Ossuetta I, Iglesias I, Theyskens C, de Jong M, Ahluwalia JS, de Zegher F, Dunger DB, , Relationship between insulin-like growth factor I levels, early insulin treatment, and clinical outcomes of very low birth weight infants., J. Pediatr., 2014, 164, 5, 1038-1044.e1, doi: 10.1016/j.jpeds.2013.12.046.
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Beardsall K, Vanhaesebrouck S, Ogilvy-Stuart AL, Ahluwalia JS, Vanhole C, Palmer C, Midgley P, Thompson M, Cornette L, Weissenbruch M, Thio M, de Zegher F, Dunger D, A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe)., BMC Pediatr, 2007, 7, 29, doi: 10.1186/1471-2431-7-29.