Neonatal hypoglycemia is a common metabolic problem in newborns that can cause neurological injury if left untreated. The Sugar Babies trial was a randomized controlled trial conducted in New Zealand that compared the effects of administering 40% dextrose gel or placebo gel to newborns at risk of hypoglycemia. The trial found that fewer babies in the dextrose gel group failed treatment compared to the placebo group. Babies receiving dextrose gel were also less likely to need additional intravenous dextrose treatment or to be admitted to the NICU specifically for hypoglycemia. The study demonstrated that dextrose gel provides an effective first-line treatment for neonatal hypoglycemia.

1. Neonatal Hypoglycaemia

2. • Overview of Neonatal Hypoglycaemia
– Why do we care?
– Detection & Prevention
– Queensland Neonatal Clinical Guideline
• The Sugar Babies Trial (Lancet 2013)
– Methods
– Findings
– Impacts on Clinical Practice

3. • Common metabolic problem in Newborns
• Glucose is the primary fuel for the brain
• Left untreated, Hypoglycaemia can cause
Neurological Injury
– mental retardation, recurrent seizure activity,
developmental delay, personality disorders and
more….

4. Depending on where you work, the definition of
Neonatal Hypoglycaemia varies.
• QLD Health
– Less than 2.6 mmol/L (47 mg/dL)
• American Academy of Paediatrics
– Less than 2.2 mmol/L (40 mg/dL) during the first 24
hours of life
– Less than 2.8 mmol/L (50 mg/dL) after 24 hours

5. Whipple's triad is a collection of three criteria that
suggest a patient's symptoms result from a ‘true
hypoglycaemia’.
1. Symptoms known or likely to be caused by hypoglycaemia
2. A low plasma glucose measured at the time of the
symptoms
3. Relief of symptoms when the glucose is raised to normal

7. • Inadequate glucose supply
– Poor feeds
– Inadequate glycogen stores
– Impaired glucose production (ie, glycogenolysis or
gluconeogenesis)
• Increased glucose utilization
(primarily due to hyperinsulinism)

8. • A baby’s risk of developing neonatal
hypoglycaemia can be due to maternal and
neonatal risk factors.
• The next two slides highlight some common
risk factors.
• Identification of risk factors is important, as it
will determine whether you screen for
hypoglycaemia.

9. • Maternal diabetes mellitus
• Intra-partum administration of Glucose
• Maternal drug therapy including:
– β-blockers
– Oral hypoglycaemic agents
– Valproate
• Family history of metabolic disorders
deficiency (e.g. Medium chain acyl-A
dehydrogenase deficiency)

10. • Prematurity (<37 weeks)
• Low Birth Weight (<less than 2500g)
• Neonates who are large (>90th percentile) or
small for gestational age (<10th percentile)
• Neonates who require intensive care (e.g.
sepsis and asphyxia)
• Inadequate feeding
• Neonates with polycythemia

12. • Regular BGLs.
• Feed immediately
– EBM
– Formula
• IV Dextrose
• Maintain close surveillance
• Pharmacological Intervention

13. • Keep Baby Warm (36.5-37.2 OC)
– Dry Baby
– Early Skin-to-Skin Contact
• Initiate early feeds within 30-60mins of birth.
– Support mother’s choice for newborn feeding
– NGT feeds if <35 weeks
– If enteral feeding is no possible, start IV Dextrose.
• Avoid Separation of Mother & Baby

17. A randomised , double-blind, placebo controlled
trial.
P: Neonates at risk of developing Hypoglycaemia
I: 40% dextrose gel (200mg/kg)
C: Placebo Gel
O: Treatment Failure and other secondary
outcomes

18. Hypoglycaemia: blood or interstitial glucose
concentration less than 2.6 mmol/L
Rebound Hypoglycaemia: further episode of
hypoglycaemia within 6hrs, after successful
treatment.
Recurrent Hypoglycaemia: further episode of
hypoglycaemia after successful treatment,
within 48 h after birth.

19. Neonates born in a tertiary hospital in
New Zealand between Dec 1, 2008, and Nov 31, 2010;
• 35+ weeks gestation
• in the first 48 hours of life
• at risk of hypoglycaemia.
Risk Factors included
– infants of diabetic mothers;
– preterm;
– small or large birthweight (i.e. less than 10th centile or over
90th centile)
– infants with poor feeding.

20. • Previous treatment for Neonatal
Hypoglycaemia
• Serious Congenital Malformation
• Terminal Disorders
• Skin conditions that would prevent the use of
continuous glucose monitoring.

22. • BSLs were measured in these babies from
one hour after birth, then every 3-4 hours
pre-feeds for the first couple of days until
hypoglycaemia was or was not detected.
• Babies who developed hypoglycaemia (BSL
<2.6) were randomised to receive either
(0.5ml/kg) or
(carboxymethyl cellulose - 0.5ml/kg).

23. • Gel was administered by rubbing into the buccal
mucosa and was then followed by a feed (or
syringe feed if the baby refused a normal feed).
• After 30 mins, if the baby was still
hypoglycaemic, the same process was repeated.
• Up to 6 doses of gel could be given over 48hrs.

26. Primary Outcome
– Treatment Failure: BGL less than 2.6mmol/L,
30 minutes after the second of two doses of gel.
Secondary Outcomes
– Admission to the NICU
– Feeding frequency
– Volume of expressed breast milk
– Need for further dextrose (IV or oral)
– Rebound hypoglycaemia;
– Time to resolve hypoglycaemia (BGLs >2.6)
– Duration of Hypoglycaemia (up to 48hrs after birth)

27. Primary outcome data were available for 116 (98%)
babies in the dextrose group, and 118 (99%) in the
placebo group.
Fewer babies in the dextrose gel group failed
treatment compared to the placebo group
(p value 0.04).
Dextrose gel
(n=118)
Placebo gel
(n=119)
Volume of Study Gel 0·84 (0·43–2·44) 0·97 (0·47–2·49)
Treatment Failure 16 (14%) 29 (24%)

28. • Babies in the dextrose gel group were less
likely to need extra doses of dextrose.
• But those who did receive intravenous
dextrose had similar amounts.
Dextrose gel
(n=118)
Placebo gel
(n=119)
Number of Babies 12 (10%) 28 (24%)
Dose (g/kg) 4·5 (0·2–10·8) 6·6 (0·2–16·2)

29. • Admission rate to NICU were similar in both
groups, but the reason for admission in the
dextrose gel group was less like to be for
hypoglycaemia.
NICU
ADMISSION
Dextrose gel
(n=118)
Placebo gel
(n=119)
Number of Babies 45 (38%) 55 (46%)
For Hypoglycaemia 16 (14%) 30 (25%)

30. • Giving dextrose gel had no adverse effects on
breastfeeding, and in fact babies in this group
were more likely to still be breastfeeding at 2
weeks. (Dextrose 5 [4%] vs Placebo 15 [13%];
RR 0·34. 95% CI 0·13–0·90; p=0·03)
• There were no adverse effects noted from the
dextrose gel.

31. • Computer generated block randomisation
• Clinician’s, family and investigators masked to
group allocation
• Groups were similar.
• Groups were treated equally.
• Losses to inclusion in analysis were explained,
justified and demonstrated to have no
significant impact on study findings.

32. A higher rate of treatment failure in the placebo
compared to the dextrose group was statistically
significant. RR 0·57 (0·33 to 0·98) | p value: 0.04
The population group in this study is similar to
population groups in Australia.
Further clarification of mechanism of action would
be useful (i.e. baby’s could have done better with
the dextrose gel due to pain relief, much like
sucrose).

33. Dextrose Gel provides a viable first-
line/intermediate treatment for neonatal
hypoglycaemia.
It’s easy to administer, keeps mother and baby
together whilst treatment is administered and is
relatively cheap.

35. References
• Queensland Maternity and Neonatal Clinical Guideline:
Newborn Hypoglycaemia
• Postnatal glucose homeostasis in late-preterm and term
infants. Pediatrics. 2011
• Harris DL, Weston PJ, Signal BE, Chase JG, Harding JE,
Dextrose gel for neonatal hypoglycaemia (the Sugar Babies
Study): a randomised, double-blind, placebo-controlled
trial, The Lancet, 2013, 382(9910): 2077-2083.
• Photos
– Anne: (17) Red is all mine!
– Garhol: Jelly Babies 02
– EMPEM.org