Liggins Institute


hPOD study: preventing brain damage in babies

A randomised controlled trial comparing prophylactic oral dextrose gel with placebo in newborn babies at risk of neonatal hypoglycaemia.

We are inviting women to take part in research that could help prevent their baby, and many more babies in the future, from getting low blood sugars (hypoglycaemia) soon after birth. This common problem can cause brain damage, and often requires baby to go into an intensive or special care unit, separating Mum and baby just as they are trying to establish breast feeding in the critical first days after birth.

Read more below

Contact the research team
Email: hpod@auckland.ac.nz
Freephone 0800 00 hPOD (0800 004 763)  

 

hPOD study


hPOD - hypoglycaemia Prevention with Oral Dextrose.

Aim

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).

Overview

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.

We recently have 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.

Harris DL, Weston PJ, Signal M, Chase JG, Harding JE. Dextrose gel for treating neonatal hypoglycaemia: A randomized placebo-controlled trial (The Sugar Babies Study). Lancet 382: 2077-83, 2013. http://dx.doi.org/10.1016/S0140-6736(13)61645-1.


Many of the children that had taken part in The Sugar Babies Study were also seen at two years of age, as part of our CHYLD (Children with Hypoglycaemia and their Later Development) Study.  From this study, we have found that hypoglycaemia, when treated as it was in Waikato Hospital, was not associated with worse developmental scores at two years of age. This suggests that the care provided for at-risk babies, including regular blood testing and early treatment of low blood sugar levels, was effective at preventing possible brain injury from hypoglycaemia. A new finding of this study was that babies who had more stable blood glucose levels in the first few days after birth had better developmental scores than those whose blood glucose levels were less stable.

McKinlay, C.J.D, Alsweiler, J.M, Ansell, J.M, Anstice, N.S, Chase, J.G, Gamble, G.D, Harris, D.L, Jacobs, R.J, Jiang, Y, Paudel, N, Signal, M, Thompson, B, Wouldes, T.A, Yu, T-Y, Harding, J.E. (2015). Neonatal Glycemia and Neurodevelopmental Outcomes at 2 Years. The New England Journal of Medicine. http://dx.doi.org/10.1056/NEJM0a1504909

Importantly, the gel is cheap, well tolerated, simple and safe to administer, and was acceptable to families and caregivers. We now wish to 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.

Study Design

  1. Dosage Trial (pre-hPOD) COMPLETED
    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.
  2. 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).

Study Methods

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.

Research Impact

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.
 

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Inclusion criteria


Babies who are at risk of hypoglycaemia, defined as satisfying at least ONE of the following:

  1. Infants of diabetic mothers (any type of diabetes)
  2. Preterm (< 37 weeks’ gestation)
  3. Small (< 2.5 kg or < 10th centile on population or customised birthweight chart)
  4. Large (> 4.5 kg or > 90th centile on population or customised birthweight chart)

AND satisfy ALL of the following:

  1. ≥ 35 weeks’ gestation
  2. Birth-weight > 2.2 kg
  3. < 1 hour old
  4. No apparent indication for NICU/SCBU admission at time of randomisation
  5. Unlikely to require admission to NICU/SCBU for any other reasons e.g. respiratory distress
  6. Mother intending to breast-feed
     
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Find out more about hPOD


Register to receive our monthly hPOD newsletter:

Email: hpod@auckland.ac.nz

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Parent information brochure
(103.9 kB, PDF)
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hPOD Parent Information brochure - Mandarin
hPOD Parent Information brochure - Mandarin (352.2 kB, PDF)
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hPOD Newsletter February 2016
hPOD Newsletter February 2016 (1.4 MB, PDF)
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hPOD Newsletter January 2016
hPOD Newsletter January 2016 (262.5 kB, PDF)
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hPOD Newsletter December 2015
hPOD Newsletter December 2015 (310.5 kB, PDF)
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Trial registration


Visit the Australian and New Zealand Clinical Trials Registration page

www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363418

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Media and funder websites


Health Research Council (HRC) - Oral gel treatment reverses low blood sugar in babies
http://www.hrc.govt.nz/news-and-media/news/oral-gel-treatment-reverses-low-blood-sugar-babies

Cure Kids: Will an oral gel prevent low blood sugar levels in at-risk newborns?
http://www.curekids.org.nz/work-you-enable/research/granting-round/will-oral-gel-prevent-low-blood-sugar-levels-risk-newborns/

The Listener - Health: Preventing neonatal hypoglycaemia
http://www.listener.co.nz/lifestyle/health/preventing-neonatal-hypoglycaemia/
 

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Investigators


Prof. Jane Harding  

Trial Investigator, Neonatal Paediatrician

Prof. Caroline Crowther      

Trial Investigator, Maternal Fetal Medicine

Dr Jane Alsweiler

Trial Investigator, Neonatal Paediatrician

Dr Jo Hegarty

Trial Investigator, Neonatal Paediatrician

Greg Gamble  

Biostatistician

Dr Richard Edlin

Health Economist

   
Siufofoga (Foga) Matagi Lead Research Midwife

Kelly Fredell         

Clinical Research Coordinator

Jenny Rogers

Research Nurse - Liggins

Robyn Wilkinson

Research Nurse - Liggins

Carla Saunders Research Nurse - Liggins
   

Safayet Hossin        

Programmer/Database Developer

Karen Frost

Programmer/Database Developer

   

Jess Wilson

Data Assistant

Grace McKnight

Data Assistant

 

 

Prof. Geoff Chase Bioengineer
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Collaborating sites


Auckland City Hospital

Currently recruiting to hPOD

Auckland Birthcare     

Currently recruiting to hPOD

Site Investigator

Dr Jane Alsweiler (Neonatologist)

   

Waitakere and North Shore Hospitals

Currently recruiting recruiting to hPOD

Site Investigator Dr Jutta van den Boom (Lead Neonatal Paediatrician)
   
Hawkes Bay Hospital Currently recruiting to hPOD (from April 2015)
Site Investigator Dr Oliver Grupp
   
Tauranga Hospital Currently recruiting to hPOD (from April 2015)
Site Investigators Drs Karina Craine and Tracey Momsen
   
Whakatane Hospital Currently recruiting to hPOD (from April 2015)
Site Investigators Dr John Malcolm and Maggie Sadlier
   

Waikato Hospital       

Currently recruiting to hPOD (from June 2015)

Site Investigator

Dr Deborah Harris

   
Southland Hospital Currently recruiting to hPOD (from February 2015)
Site Investigator Dr Paul Tomlinson

Are you another site which would like to be involved?
Contact the trial investigators for more information: Email hpod@auckland.ac.nz

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Other collaborators


This project involves collaboration between the Liggins Institute and The University of Canterbury Department of Mechanical Engineering.

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Data and safety monitoring committees


Data Monitoring Committee

Professor Frank Bloomfield (Chair)
Dr Katie Groom
Dr Thomas Lumley

 

Safety Monitoring Committee

Dr Carl Kuschel (Chair)
Dr Malcolm Battin
Dr Lindsay Mildenhall

 


 

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Funding


We gratefully acknowledge funding from the following sources:

  • A+ Trust
  • Auckland Medical Research Council (AMRF)
  • Cure Kids
  • Gravida: National Research Centre for Growth and Development
  • Health Research Council (HRC)
  • Lotteries
  • University of Auckland Foundation grant
     
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Training videos


Measuring blood glucose (sugar) levels using an iSTAT handheld blood glucose analyser

  1. Learn how to fill the cartridge with a blood sample to test blood sugar (glucose) using an iSTAT handheld blood gas analyser
    Watch the video here

  2. An updated video will be posted here soon.
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Contact


Register to receive our monthly hPOD newsletter: Email hpod@auckland.ac.nz
Contact the trial investigators Email: hpod@auckland.ac.nz
Freephone 0800 00 hPOD (0800 004 763) to speak with a member of the clinical research team.
 

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