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Neonatal Insulin Replacement Therapy in Europe

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78428828
Enrollment
500
Registered
2004-09-30
Start date
2002-04-25
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine: Hyperglycaemia Nutritional, Metabolic, Endocrine Hyperglycaemia

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 u

Sponsors

Cambridge University Hospitals NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Maternal diabetes including gestational diabetes 2. Babies where the appropriateness of continuing intensive care is being discussed 3. Major congenital anomalies

Design outcomes

Primary

MeasureTime frame
Death on or before expected date of delivery.

Secondary

MeasureTime frame
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

Countries

Belgium, Netherlands, Spain, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026