Neonatal Insulin Replacement Therapy in Europe
| ISRCTN | ISRCTN78428828 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78428828 |
| Secondary identifying numbers | N0544112291 (pilot study reference on NRR) |
- 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
Scientific
Box No 116
University Dept of Paediatrics
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 336886 |
|---|---|
| dbd25@cam.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 25/04/2002 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 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
- Belgium
- England
- Netherlands
- Spain
- United Kingdom
Study participating centre
Box No 116
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
R&D Department
Box 146
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom
| Phone | +44 (0)1223 596377 |
|---|---|
| sabine.klager@addenbrookes.nhs.uk | |
| Website | http://www.addenbrookes.nhs.uk |
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Industry
Medtronic and Novonordisk
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/08/2007 | Yes | No | |
| Results article | results | 30/10/2008 | Yes | No | |
| Results article | results | 01/05/2014 | Yes | No |
