A randomised controlled trial comparing prophylactic oral dextrose gel with placebo in newborn babies at risk of neonatal hypoglycaemia.
Recruitment to this phase of the study is now complete. Thank you to all who supported and contributed to this important trial.
The aim of hPOD (hypoglycaemia Prevention with Oral Dextrose) is to determine whether oral dextrose gel, given to babies at risk of hypoglycaemia shortly after birth, will prevent neonatal hypoglycaemia and, therefore, admission to the newborn intensive care unit or special care baby unit (NICU/SCBU).
Background to the study
Hypoglycaemia is the commonest metabolic disorder of the newborn, and the only known common preventable cause of brain damage in newborn babies. Up to 15% of newborn babies will have low blood glucose concentrations, and the rate is much higher in babies who have additional risk factors: up to 50% in babies of diabetic mothers and 66% in preterm babies. Neonatal hypoglycaemia can cause brain damage and death, and its treatment commonly requires admission to the newborn intensive care unit or special care baby unit (NICU/SCBU), separating mothers and babies and interfering with the establishment of breast-feeding, thus incurring high social and financial cost.
A previous study (the Sugar Babies Study) demonstrated that treatment of neonatal hypoglycaemia with oral dextrose gel was more effective than feeding alone in reversing hypoglycaemia, and reduced both the rate of NICU admission for hypoglycaemia and the rate of formula feeding at two weeks of age.
Importantly, the gel is cheap, well tolerated, simple and safe to administer, and was acceptable to families and caregivers. hPOD and the follow-up study will determine whether oral dextrose gel is effective in preventing hypoglycaemia and admission to NICU/SCBU, and so preventing many of the adverse effects associated with this common problem.
- Dosage Trial (pre-hPOD)
The first stage of this research was a trial to determine the dose of dextrose gel that should be used for the hPOD trial. This was a randomised, placebo-controlled trial, comparing two doses (0.5 ml/kg or 1.0 ml/kg) of 40% dextrose gel with an identical appearing placebo gel, given either once only or an additional three times before feeds in the first 12 hours. The most effective, acceptable and safe dose of dextrose gel that prevents neonatal hypoglycaemia was found to be a single dose of 40% dextrose gel at 0.5ml/kg. Completed: November 2014
- Multicentre Trial (hPOD)
This is a multicentre, randomised, placebo controlled trial to determine if dextrose gel is more effective than an identically appearing placebo to prevent admission to a newborn intensive care unit or special care baby unit (NICU/SCBU). Completed: May 2019
Babies who are at risk of hypoglycaemia (infants of diabetic mothers, preterm, small or large) and unlikely to require NICU admission for other reasons are randomised by computer to receive hPOD study gel which is either 40% dextrose gel or identically appearing placebo gel.
hPOD study gel is massaged into the inside of the cheek soon after birth, and babies are managed according to the usual hospital protocol, including blood glucose measurement at 2 hours of age and intermittently thereafter.
The problem we are addressing is common and becoming ever more so: the rate of maternal diabetes in New Zealand, for example, has quadrupled from 2% in 1991 to 8% in 2010, and is most common in Māori and Pasifika mothers. This novel study is the first to investigate whether neonatal hypoglycaemia can be prevented by a simple, cheap and painless intervention.
We also plan an economic evaluation of the intervention. Currently 10% of at-risk babies (~2,100 a year) require NICU admission. With admission to NICU costing $1,500 a day, and a mean length of admission of 3 days, this problem costs some $9.4 million per year in NICU costs alone. Thus, a successful, cheap intervention would not only prevent a potentially brain damaging condition, but would result in significant economic benefit for New Zealand’s healthcare system.
If successful, this intervention is likely rapidly to transform the management of neonatal hypoglycaemia, particularly as it requires no special expertise or equipment and hence is applicable in almost any birth setting.
Babies who are at risk of hypoglycaemia, defined as satisfying at least ONE of the following:
- Infants of diabetic mothers (any type of diabetes)
- Preterm (< 37 weeks’ gestation)
- Small (< 2.5 kg or < 10th centile on population or customised birthweight chart)
- Large (> 4.5 kg or > 90th centile on population or customised birthweight chart)
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 breastfeed
Distinguished Professor Jane Harding
Professor Caroline Crowther
Dr Jane Alsweiler
Dr Jo Hegarty
Dr Richard Edlin
The pre-hPOD Trial was conducted in Auckland City Hospital and Waitakere Hospital, New Zealand.
The main hPOD Trial was conducted in eighteen hospitals across New Zealand and Australia.
New Zealand recruiting centres: Auckland City Hospital, Hawkes Bay Hospital, North Shore Hospital, Southland Hospital, Tauranga Hospital, Waikato Hospital, Waitakere Hospital, Whakatane Hospital and Whangarei Hospital.
Australian recruiting centres: Angliss Hospital, Box Hill Hospital, Mackay Base Hospital, Tamworth Rural Referral Hospital, The Mater Hospital (Sydney), Townsville Hospital, University Hospital Geelong, Westmead Hospital and Women’s and Children’s Hospital, Adelaide.
Find out more about hPOD
Trial-related enquiries may be emailed to the Principal Investigator, Distinguished Professor Jane Harding, email email@example.com
Enquiries regarding the hPOD 2YR Follow-up Study may be emailed to: firstname.lastname@example.org