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

Hyperglycaemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419873
• Other study ID #: URA/08/06/039
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2011
• Last updated: August 25, 2011
• Start date: August 2008
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: Christchurch Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Hyperglycaemia
• Hyperglycemia

Intervention

Drug:
• Actrapid Human Insulin
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

Locations

Country	Name	City	State
New Zealand	Christchurch Womens Hospital, Canterbury District Health Board	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Christchurch Women's Hospital

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes