None listed
Conditions
Brief summary
Hypoglycaemia is the commonest metabolic condition of the newborn. It affects up to 15% of babies, and the incidence is increasing as risk factors such as maternal diabetes and preterm birth are becoming more common. Neonatal hypoglycaemia frequently leads to neonatal intensive care unit (NICU) admission and may cause long-term brain damage. There currently are no evidence-based strategies to prevent hypoglycaemia and its adverse consequences. The purpose of this trial is to find the dose of prophylactic oral dextrose gel which will prevent neonatal hypoglycaemia when administered to newborn babies at risk of hypoglycaemia. The most effective, acceptable and safe dose of dextrose gel will be used in a multicentre trial to determine whether prophylactic dextrose gel prevents admission to NICU.
Interventions
This trial is a dosage trial to determine the most effective dose and frequency of 40% dextrose gel in preventing hypoglycaemia.
There will be 8 arms, 4 intervention and 4 placebo.
All doses will be administered by massage into the buccal mucosa immediately prior to a breastfeed, beginning with the first feed no later than one hour after birth.
Intervention arms - 40% dextrose:
Arm 1 Single dose arm; 200mg/kg (0.5ml/kg) before first feed
Arm 2 Multiple dose arm; 200mg/kg (0.5ml/kg) given pr
This trial is a dosage trial to determine the most effective dose and frequency of 40% dextrose gel in preventing hypoglycaemia. There will be 8 arms, 4 intervention and 4 placebo. All doses will be administered by massage into the buccal mucosa immediately prior to a breastfeed, beginning with the first feed no later than one hour after birth. Intervention arms - 40% dextrose: Arm 1 Single dose arm; 200mg/kg (0.5ml/kg) before first feed Arm 2 Multiple dose arm; 200mg/kg (0.5ml/kg) given pre-feed, before the first four feeds Arm 3 Single, higher dose arm; 400mg/kg (1ml/kg) before first feed Arm 4 Multiple, higher dose arm; 400mg/kg (1ml/kg) before first feed, followed by 200mg/kg (0.5ml/kg), given pre-feed, before the next three feeds The most effective dose will subsequently be used in a multicentre trial with a primary outcome of reduction in admission to NICU. The multicentre trial will be registered with ANZCTR separately.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 1 Hours
Healthy volunteers
No
Inclusion criteria
Babies who are at risk of hypoglycaemia, defined as satisfying AT LEAST ONE of the following: 1. Infants of diabetic mothers (any type of diabetes) 2. Preterm (< 37 weeks' gestation) 3. Small (< 2.5kg or < 10th centile on population or customised birthweight chart) 4. Large (> 4.5kg or > 90th centile on population or customised birthweight chart) 5. Other risk e.g. maternal medication AND satisfy ALL of the following: 1. > or = 35+0 weeks' gestation 2. Birthweight > 2.2kg 3. < 1 hour old 4. No apparent indication for NICU/SCBU admission at time of randomisation 5. Unlikely to require admission to NICU/SCBU for any other reason e.g. respiratory distress 6. Mother intending to breastfeed.
Exclusion criteria
1. Major congenital abnormality 2. Previous formula feed or intravenous fluids 3. Previous diagnosis of hypoglycaemia 4. Admitted to NICU/SCBU 5. Imminent admission to NICU/SCBU
Outcome results
None listed