Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
03/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.addenbrookes.nhs.uk

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes