Oral dextrose gel for prevention of neonatal hypoglycaemia
Jo Hegarty
Neonatologist, ADHB
On behalf of the hPOD Steering Group:
Hegarty JE, Alsweiler JM, Gamble GD, Crowther CA, Edlin R, Harding JE
Baby - www.flickr.com/photos/radloff/ MRI - Barkovich AJNR Am J Neuroradiol 19:523–528, March 1998 Heel prick – Bethan Jones, hPOD Research Nurse
Pre-hPOD (dosage trial)
To determine the dose of prophylactic oral
dextrose gel which will prevent neonatal
hypoglycaemia when administered to
newborn babies at risk of hypoglycaemia.
pre-hPOD
Eligible babies
Single dose arm
200mg/kg
(0.5 ml/kg)
glucose
400mg/kg
(1 ml/kg)
glucose
1 ml/kg
placebo
0.5 ml/kg
placebo
multiple dose arm
200mg/kg
(0.5 ml/kg)
glucose
400mg/kg
(1 ml/kg)
glucose
1 ml/kg
placebo
0.5 ml/kg
placebo
200mg/kg
(0.5 ml/kg)
glucose
0.5 ml/kg
placebo
At 1
ho
ur
Pre
fee
d x
3
do
se
s
Inclusion criteria
At risk of hypoglycaemia; at least ONE of:
– Infants of diabetic mothers (any type)
– Preterm (< 37 weeks)
– Small (< 2.5 kg or < 10th centile, population or customised)
– Large (> 4.5 kg or > 90th centile, population or customised)
– Other
AND satisfy ALL of the following:
– ≥ 35 weeks’ gestation
– Birth-weight ≥ 2.2 kg
– < 1 hour old
– No apparent indication for NICU/SCBU admission at time of randomisation
– Unlikely to require admission to NICU/SCBU for any other reasons e.g. respiratory distress
– Mother intending to breast-feed
0 2 0 0 4 0 0 8 0 0 1 0 0 0
0 .0
0 .5
1 .0
1 .5
Od
ds
of
[blo
od
glu
co
se
] <
2.6
mM
in f
irs
t 4
8h
ou
rs
C u m m u la tiv e D o s e D e x tro s e (m g /k g )
7 2 /1 3 8 2 5 /6 6 3 4 /7 3 2 8 /6 8 2 7 /7 0
(52%) (3 8 % ) (4 7 % ) (4 1 % ) (3 9 % )
Results
Results
8
Prophylactic oral dextrose gel in babies at risk
reduced the incidence of hypoglycaemia
The most effective dose was a single dose of
0.5 ml/kg
main-hPOD
• 2,129 babies
• Primary outcome: Admission to NICU
• Commenced randomisation January 2015
• Currently 8 centres recruiting in NZ
• CTA/ethics Australia – additional 14 sites
• 503 recruited as of 18 Aug
• MCNZ - 5 professional activity
• points for significant contribution
Primary outcomes
Neurosensory impairment
Processing difficulty (motion coherence and executive function)
Progress
• 259/415 seen • 91% retention rate
Follow-Up Study: hPOD-FU@2
10
Paula
Harre
Malcolm
Battin
Jutta van
den Boom
Thank you!
Extra slides
12
Results
