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Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates

C

Christchurch Women's Hospital

Status and phase

Completed
Phase 4

Conditions

Hyperglycaemia

Treatments

Drug: Actrapid Human Insulin

Study type

Interventional

Funder types

Other

Identifiers

NCT01419873
URA/08/06/039

Details and patient eligibility

About

Very low birthweight neonates commonly develop high blood sugar levels. There is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually causes the problems.

There are a range of ways to manage high sugar levels but there are no consensus guidelines to follow. One option is to manage the high sugar levels with an infusion of insulin. Studies looking at insulin infusions have often used fixed protocols to guide the amount of insulin to be given and are often complicated by hypoglycaemia.

This study investigated whether using a model-based approach to individualise insulin administration to neonates with high sugar levels would provide a safe and effective management option for controlling blood sugar levels and avoid the complication of low blood sugar levels.

Enrollment

30 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Birthweight <1500g
  • Blood sugar >/= 10mmol/L
  • Clinician decision to start an insulin infusion

Exclusion criteria

  • Infants who were moribund and not expected to survive

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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