Skip to main content
Clinical Trials/NCT01419873
NCT01419873
Completed
Phase 4

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

Christchurch Women's Hospital1 site in 1 country30 target enrollmentAugust 2008

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Hyperglycaemia
Sponsor
Christchurch Women's Hospital
Enrollment
30
Locations
1
Primary Endpoint
Hypoglycaemia whilst receiving insulin
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2008
End Date
June 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Christchurch Women's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Adrienne Lynn

Dr Adrienne Lynn

Christchurch Women's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hypoglycaemia whilst receiving insulin

Time Frame: Length of hospital stay in NICU which will be from birth to 5 months of age

Hypoglycaemia whilst the patient is receiving insulin as per the model-based method will be documented. The patients may require insulin at any time in their admission to NICU from birth to a maximum of 5 months of age when they would no longer be admitted to NICU.

Study Sites (1)

Loading locations...

Similar Trials