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