Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 12, 2011
CompletedFirst Posted
Study publicly available on registry
August 18, 2011
CompletedAugust 29, 2011
August 1, 2011
2.8 years
August 12, 2011
August 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hypoglycaemia whilst receiving insulin
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.
Length of hospital stay in NICU which will be from birth to 5 months of age
Interventions
Actrapid Insulin is a drug used in routine neonatal practice to treat hyperglycaemia. The intervention in this study was to base dosing on insulin by a computer based-model approach as opposed to sliding scales, fixed protocols or clinician intuition
Eligibility Criteria
You may qualify if:
- Birthweight \<1500g
- Blood sugar \>/= 10mmol/L
- Clinician decision to start an insulin infusion
You may not qualify if:
- Infants who were moribund and not expected to survive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Christchurch Womens Hospital, Canterbury District Health Board
Christchurch, New Zealand
Related Publications (1)
Le Compte AJ, Lynn AM, Lin J, Pretty CG, Shaw GM, Chase JG. Pilot study of a model-based approach to blood glucose control in very-low-birthweight neonates. BMC Pediatr. 2012 Aug 7;12:117. doi: 10.1186/1471-2431-12-117.
PMID: 22871230DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrienne M Lynn, FRACP
Canterbury District Helath Board
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Adrienne Lynn
Study Record Dates
First Submitted
August 12, 2011
First Posted
August 18, 2011
Study Start
August 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 29, 2011
Record last verified: 2011-08