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
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