Take part in a clinical trial
Take part in a clinical trial and help put research into practice. It's a valuable way to turn scientific discoveries into real-life applications that could benefit the health of people of all ages.
About our clinical trials and studies
An important part of the work at Liggins is putting research into practice. Our clinicians follow babies, children and pregnant women to assess potential health risks that could be associated with the pre-birth environment or treatments during the neonatal period.
Nutrition throughout life is another important aspect of maintaining health and reducing the risk of disease. The Liggins Institute also conducts trials in adults to investigate how particular groups of people respond to specific food components.
Randomised controlled trials and observational studies are carried out either in hospitals, at the Liggins’ purpose-built Maurice and Agnes Paykel Clinical Research Unit, or at the Nutrition and Mobility Clinic at the University’s Grafton campus. Our fully equipped facilities allow complex metabolic studies to be performed on children, young people and adults.
All clinical studies are approved by the New Zealand Ministry of Health’s Health and Disability Ethics Committees.
Studies recruiting pregnant women, mothers and babies
Our research aims to give all babies a healthy start for a healthy life but some babies, for example those born early, very small, very large or to mothers with gestational diabetes, face greater challenges. Our clinical trials and follow-up studies are designed to help babies and mothers improve their chances of a healthy life and we are inviting eligible mothers and babies to take part in the following studies:
hPOD: preventing neonatal hypoglycaemia with oral dextrose gel
Low blood sugar or hypoglycaemia is the only known preventable cause of brain damage in newborn babies. It affects up to 15% of babies and often requires babies to be admitted to intensive care units for treatment, separating mothers and babies and interfering with breastfeeding. Babies are most at risk if they are born early, born small or large for gestational age, or born to mothers with diabetes.
We recently showed hypoglycaemia could be treated with a dextrose (sugar) gel rubbed inside babies' mouths. The hPOD study aims to find out if we can use this gel to prevent low blood sugars in newborns if it is given to at risk babies soon after birth.
GEMS:Gestational Diabetes Mellitus Study of Detection Thresholds
Gestational diabetes (GDM) affects one in every 12 pregnant women in New Zealand but there is no consensus on the degree of high blood glucose needed for the diagnosis of GDM or when treatment will be beneficial.
The GEMS study is recruiting 9,000 mothers and babies across Auckland to compare important health outcomes for mothers and babies treated by the current NZ criteria, with those treated by newly proposed criteria that use a lower threshold and will diagnose more women as having GDM.
Find out how to enrol yourself or a woman in your care.
MAGENTA: Magnesium sulphate at 30 to 34 weeks’ gestational age: neuroprotection trial
Babies born very preterm have a higher chance of dying in the first few weeks of life and those who survive have a greater risk of neurological impairments such as cerebral palsy. Previously, we have shown that magnesium sulphate, if given before 30 weeks’ gestation, helps to increase the chances of the baby surviving, and without cerebral palsy.
MAGENTA is a randomised controlled trial to assess whether giving pregnant women magnesium sulphate prior to preterm birth between 30 and 34 weeks gestation also reduces these risks.
As part of MAGENTA, babies recruited in Auckland and Christchurch will be able to have an MRI to image the baby’s brain.
If you think you may be eligible to participate please talk to your Lead Maternity Carer (LMC).
TARGET: Optimal Glycaemic Targets for Gestational Diabetes
Gestational diabetes (GDM) is a significant health problem affecting one in every 12 pregnant women, or over 5,200 women, in New Zealand annually. GDM has a major, negative impact on maternal and perinatal health with lifelong consequences.
The TARGET study is recruiting over 1000 mothers and babies at ten sites across New Zealand. The study aims to understand if the implementation of tighter treatment targets for blood sugar control has differential outcomes for mothers with GDM and their babies, compared to current, less stringent targets. The trial will compare the relative risk of the baby being born large for gestational age, which is strongly associated with early life and later health problems.
The uniquely designed trial will establish if there are true benefits, without harm, to tighter treatment targets.
Find out how you can enrol in the TARGET study.
Neonatal Intensive Care Unit (NICU) studies
Clinical researchers at the Liggins are investigating ways to improve clinical care for small and preterm infants during the vulnerable neonatal period and improve their long-term health outcomes. Clinical research includes involvement in large, multi-centre international randomised controlled trials (RCTs), as well as locally conducted RCTs.
If your baby has been admitted to NICU, you may be invited to take part in one of these studies.
FLORA: Flow at Lower Rates
Approximately 50% of babies born before 28 weeks’ gestation develop respiratory disease and have an ongoing need for breathing support past 36 weeks’ corrected gestation. These babies generally require longer hospitalisation, more frequent re-admission to hospital and have a higher risk of developing asthma.
FLORA is a randomised controlled trial using new approaches to optimise ventilation practices and reduce chronic lung disease in extremely preterm babies.
FLORA is recruiting extremely preterm babies in neonatal intensive care units throughout NZ. If you think your baby is eligible please talk to your newborn intensive care team about taking part in this study.
HINT2: Hyperglycaemia (high blood sugar) and Insulin in Neonates Trial
High blood sugar levels (hyperglycaemia) are common in very small babies and are associated with poor outcome, including potential brain injury and death. Hyperglycaemia is usually treated with insulin, but in very small babies it can be difficult to determine the correct dose; and requirements change rapidly. This means that the babies’ blood sugar levels can fall too low (hypoglycaemia) putting them at further risk of brain damage.
HINT2 is trialling the effectiveness of a specially developed computer model that aims to improve control of blood glucose concentrations in babies being treated with insulin, and reduce the incidence of hypoglycaemia
HINT2 is recruiting very small babies (born at ≤ 1500g or ≤ 30 weeks) who are being treated with insulin in newborn intensive care units (NICUs) in NZ. If you think your baby is eligible please talk to your newborn intensive care team about taking part in this study, or email our coordinating neonatologist, Dr Kate Williamson: email@example.com.
PROVIDE: Protein intravenous nutrition for extremely low birth weight babies: impact on development
Being born very small has long term effects on growth and neurodevelopment. Up to 50% of extremely low birth weight babies experience some neurodevelopmental impairment in childhood.
ProVIDe is a randomised controlled trial investigating how increasing protein intake in the first days after birth in extremely low birth weight babies affects their growth, metabolic, and neurodevelopmental outcomes.
There is international agreement that increased protein intake in the neonatal period improves both growth and neurodevelopment, however the optimal amount of protein required is not known.
ProVIDe is recruiting very low birth weight babies (<1000 g) in all neonatal intensive care units (NICUs) in NZ. If you think your baby might be eligible when they are born, please talk to your obstetrician, delivery team and newborn intensive care team, either before baby is born or immediately after – babies need to be enrolled within 24 hours of birth.
For more information email Barbara Cormack: firstname.lastname@example.org
NiPPeR: Nutritional Intervention Preconception and during Pregnancy to maintain healthy glucosE levels and offspRing health
The NiPPeR study is examining the impact of nutrients before and during pregnancy on the health of mothers and their babies. Increasing evidence shows the mother’s nutritional state as she enters pregnancy is important for the baby’s development. For example, if the mother has high blood sugar levels it can predispose the baby to having increased body fat in later life.
In this study mothers are given a combination of nutrients and probiotics before and during pregnancy to investigate the effects on maintaining healthy blood sugar, vitamin and mineral levels in the mother, and the potential to promote a healthy pregnancy and healthy growth and development of the child. In addition, the study will evaluate the impact on the activity of the baby’s genes (so-called “epigenetic” mechanisms).
The study will recruit 600 women in Central and South Auckland aged between 18-38 who want to get pregnant in the next six months. If you'd like to take part, please visit the NiPPeR website for more information.
Follow up studies during childhood
Families whose babies have been through neonatal intensive care units are frequently invited to participate in follow-up studies of perinatal care. We are also currently following-up specific groups of children who took part in the A*TEROID, CHYLD and PIANO studies. If you are eligible to take part in these studies, you should be contacted by a member of the study team. You can read more about these studies on the LiFePATH Clinical Research page.