Neonatal Insulin Replacement Therapy in Europe

ISRCTN	ISRCTN78428828
DOI	https://doi.org/10.1186/ISRCTN78428828
Protocol serial number	N0544112291 (pilot study reference on NRR)
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funder	Medtronic and Novonordisk

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 03/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David B Dunger
Scientific

Box No 116
University Dept of Paediatrics
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 336886
Email	dbd25@cam.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	NIRTURE
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Insulin
Primary outcome measure(s)	Death on or before expected date of delivery.
Key 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
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	500
Key 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
Key exclusion criteria	1. Maternal diabetes including gestational diabetes 2. Babies where the appropriateness of continuing intensive care is being discussed 3. Major congenital anomalies
Date of first enrolment	25/04/2002
Date of final enrolment	01/01/2008

Locations

Countries of recruitment

United Kingdom
England
Belgium
Netherlands
Spain

Study participating centre

Box No 116

Cambridge
CB2 2QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	30/10/2008	Yes	No
Results article	results	01/05/2014	Yes	No
Protocol article	protocol	10/08/2007	Yes	No