RecruitingACTRN12614000492651

Hyperglycaemia in Neonates Trial: Computer determined insulin dosage in the management of neonatal hyperglycaemia

In preterm babies with neonatal hyperglycaemia is a computer determined insulin dosage more effective than standard medical care in reducing episodes of insulin-induced hypoglycaemia.

Sponsor

University of Auckland; Department of Paediatrics: Child and Youth Health

Enrollment

138 participants

Start Date

Oct 11, 2014

Study Type

Interventional

Conditions

Neonatal Hyperglycaemia

Summary

Neonatal hyperglycaemia is common in preterm babies and is associated with an increased incidence of mortality and major morbidity, which may lead to a poor neurodevelopmental outcome. Neonatal hyperglycaemia often is treated with an insulin infusion. However, there are limited data for this practice in the preterm population with no data on long-term outcomes. Furthermore, insulin increases the risk of hypoglycaemia, which is associated with poor neurodevelopmental outcome in preterm babies. Thus, on the one hand hyperglycaemia in preterm babies may be associated with adverse outcomes, but on the other hand the most common treatment for hyperglycaemia, insulin therapy, increases the risk of hypoglycaemia, which also may increase the risk of adverse neurodevelopmental outcomes. A computer model that determines insulin dosing based on insulin sensitivity and nutritional intake in hyperglycaemic preterm babies has been developed by bioengineers at the University of Canterbury. This technique has been shown to reduce the risk of hypoglycaemia compared with historic controls and is now in routine use at Christchurch Women’s Hospital NICU. However, further testing is required to show the model is effective before it is incorporated into clinical practice throughout New Zealand and internationally. We propose a randomised, controlled trial of computer determined insulin dosage in hyperglycaemic preterm babies to determine if this technique reduces the risk of hypoglycaemia, and improves neonatal growth and long-term outcome. If this technique is proven to be successful this could provide a safer way of administering insulin in vulnerable preterm babies, potentially improving neurodevelopmental outcome.

Eligibility

Sex: Both males and femalesMin Age: 23 WeekssMax Age: 37 Weekss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a computer-determined insulin dosing system can reduce the risk of dangerous low blood sugar (hypoglycaemia) in premature babies who develop high blood sugar (hyperglycaemia) in the newborn intensive care unit. Premature babies often have unstable blood sugar, and both too-high and too-low levels can harm their brain development. The computer model adjusts insulin doses based on each baby's individual needs. You may be eligible if: - Your baby was born before 30 weeks of pregnancy or weighed less than 1,500 grams at birth - Your baby has developed hyperglycaemia (high blood sugar on two consecutive readings) - You as a parent are able to give written informed consent You may NOT be eligible if: - Your baby has a congenital abnormality affecting life expectancy or brain development - Your baby has already received insulin treatment before the study - Your baby is considered at risk of imminent death Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Arm 1: Computer Determined Insulin Dosage, insulin dose calculation by computer model, timing of blood glucose measurements determined by computer model. The computer model is available on a comput

Arm 1: Computer Determined Insulin Dosage, insulin dose calculation by computer model, timing of blood glucose measurements determined by computer model. The computer model is available on a computer tablet at the cot side. Medical staff will input the following data parameters: Gestational age, weight, current nutrition (IV dextrose and enteral feeds) and current blood glucose concentration. Using this data the model calculates current insulin sensitivity for the individual baby. Further calculations by the model will produce a suggested insulin dose which will most likely result in achieving a blood glucose concentration within the appropriate target range of 5-8 mmol / L. The model will also advise the staff when to measure the next blood glucose concentration. Duration of intervention: for the time period the baby is receiving an insulin infusion. Arm 2: Bedside Titration, insulin dose calculation by medical staff, timing of blood glucose measurements determined by computer model. Medical staff will use the current standard practice for prescribing insulin. Standard practice is supported with local protocols and clinical experience. The clinicians will decide a suitable dose of insulin to be prescribed. The computer model will only be used to advise when the next blood glucose concentration should be measured. Duration of intervention: for the time period the baby is receiving an insulin infusion. Arm 3: Standard Care, insulin dose and timing of blood glucose measurements determined by medical staff. Medical staff will use the current standard practice for prescribing insulin. Standard practice is supported with local protocols and clinical experience. The medical staff will also decide when the next blood glucose concentration should be measured. Duration of intervention: for the time period the baby is receiving an insulin infusion.

Locations(1)

New Zealand

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ACTRN12614000492651