Neonatal


Trials to achieve healthy outcomes for mothers and babies are challenging. We work with clinicians through global partnerships, aiming to find cost-effective treatments that will reduce infant mortality and illness.

Our aim is to investigate areas of need such neonatal infection, oxygen therapy and simple cost effective measures to reduce neonatal problems.

The data from our latest trials are being combined with data from similar trials in other countries for prospective meta-analysis of data from many thousands of patients. We have participated or taken a lead in setting up networks of investigators who are making this happen. 

 

Planned trials -  Coming soon!


Active trials - Recruiting

The Lactoferrin Evaluation in Anaemia in Pregnancy (LEAP-1) study will evaluate the effects of oral bovine lactoferrin versus iron sulphase in iron deficiency anaemia in pregnancy. The study aims to see if bovine lactoferrin administration during pregnancy improves foetal growth and neonatal iron status at birth.

The PAEAN study will examine the effect of erythropoietin in near-term babies who have suffered from low blood or oxygen supply to the brain at birth. PAEAN aims to find out whether erythropoietin in addition to the standard of care treatment increases survival without moderate to severe disability at 2 years of age.

The PROTECT study will evaluate the effect of pentoxifylline for preterm babies with late-onset sepsis or necrotizing enterocolitis. The study aims to see if pentoxifylline improves survival without disability in these babies.

The TORPIDO2 study is trying to find out how much oxygen is best for very premature babies. It will compare short and long term outcomes of premature babies who have had one of two different but commonly used levels of oxygen, to see if using higher or lower levels in the perios just after birth is better the for baby in the short and long term.

 

Active trials - Follow-up

The Australian Placental Transfusion Study (APTS) will determine whether a 60-second delay in clamping and cutting the cord can improve the baby's blood flow to the brain and gut, reduce the need for donor blood, and reduce rates of infection, retinopathy, poor growth, death and disability in babies born more than 10 weeks early.

The Lactoferrin Infant Feeding Trial (LIFT) will evaluate the effects of treatment with bovine lactoferrin in breast milk or formula feeds for infants weighing less than 1500g at birth. The aim of the study is to see if adding bovine lactoferrin to feeds increases survival without major morbidity in very low birth weight infants.

 

Closed trials

BOOSTII (Benefits of Oxygen Saturation Targeting, trial II) will ascertain which of two oxygen saturation ranges is better for very premature babies. Oxygen is the most common therapy for preterm infants. Doctors and nurses do not know the safe and effective level of oxygenation for these babies. Higher oxygen levels may increase retinopathy of prematurity and respiratory problems, but lower oxygen levels may affect other long-term outcomes. BOOST II has recruited 1135 infants in Australia (a total of 1475 with the recruitment by our colleagues in New Zealand). Go to the BOOSTII homepage here.

The INIS trial (International Neonatal Immunotherapy Study) assessed the effects of nonspecific intravenous immunoglobulin in addition to antibiotics in babies with severe infections. This trial is now closed after enrolling just under 3500 infants. Our global partners are in New Zealand, the United Kingdom and Argentina.

Quick links

BOOST II

APTS