Very low birth weight infants requiring intensive care have relative insulin deficiency often leading to hyperglycaemia during the first week of life. There is increasing evidence that the early postnatal period is critical for pancreatic development. This has implications both in terms of acute glucose control but also relative insulin deficiency is likely to play a role in poor postnatal growth, which has been associated with later motor and cognitive impairment.
Conditions
Interventions
Trade Name: NovoRapid
Product Name: NovoRapid
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Insulin aspart
CAS Number: 116094-23-6
Other descriptive name: Novo rapid
Concentration uni
Sponsors
Cambridge University Hospital (Addenbrookes Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i) =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i) Maternal diabetes including gestational diabetes ii) Babies where the appropriateness of continuing intensive care is being discussed iii) Major congenital anomalies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether an early fixed dose insulin infusion, combined with variable dextrose support to maintain normoglycaemia, will reduce mortality at 28 days of age in the very low birth weight neonate.;Secondary Objective: total number of days in neonatal intensive care prior to discharge home; (ii) episodes of sepsis in the first 2 weeks of life; (iii) growth at 28 days; (iv) severity of retinopathy of prematurity; (v) incidence of necrotizing enterocolitis (vi) incidence of intracranial haemorrhage (vii) chronic lung disease (viii) mortality before expected date of delivery ;Primary end point(s): Efficacy outcomes (i) Blood glucose control over the first week of life as assessed by the MiniMed subcutaneous continuous glucose monitor (CGMS) Primary outcome: Death within and including the first 28 days after delivery (where day 1 is considered as the first day of life) Secondary outcomes: i. Days of Neonatal Intensive Care: As defined by BAPM 200140 (appendix 1). ii. Episodes of sepsis in the first 2 weeks: a) Culture positive systemic infection will be defined as microbiologically positive cultures of blood, cerebrospinal fluid or suprapubic aspirate of urine plus clinical signs of sepsis. b) Culture negative infection will be defined as clinical signs suggestive of sepsis and considered to warrant >48 hours of antibiotics but with negative cultures. iii. Growth: All babies will have measurements of weight, length and head circumference at birth and every seven completed days after recruitment until 28 days of age. Growth will be assessed as change in weight, length and head circumference standard deviation score (SDS) from birth to 28 days of age. iv. Retinopathy of Prematurity: All these babies will be routinely screened (appendix 1), for retinopathy of prematurity and will be graded using the internationally recognised grading system 41,42 (appendix 1). Infants will be classified by the most severe degree of retinopathy. v. Incidence of | — |
Countries
Spain
Outcome results
None listed