Neonatal Research

SUpporting Mothers Milk Intervention Trial (SUMMIT): A randomized controlled trial comparing different doses of domperidone for treating lactation insufficiency in mothers of preterm infants

Comparing high (60mg) vs low (30mg) dose Domperidone to increase expressed breast milk volumes in mothers of preterm infants with lactation insufficiency.

Mothers of preterm infants often struggle to produce enough breast milk to meet the daily feed requirements of their infants, especially in the longer-term. This randomized multi-centre double-blind parallel controlled trial will resolve the issue of whether a higher dose of domperidone (60 mg/day) leads to greater improvements in maternal breast milk supply compared to a lower dose (30 mg/day), while also evaluating differences in adverse events, impacts on breast milk composition, and identifying predictors of treatment response to domperidone. 

• Site PI: Dr Ranmali Rodrigo
• Status as of October 2025: Enrolments close at the end of 2025.

Find out more about the trial here: ANZCTR SUMMIT

NIMBUS

Innovative MRI and blood based predictive tools to guide interventions following neonatal arterial ischaemic stroke.

In this study, we address the most important questions that parents ask their treating obstetrician or neonatologist: Why did my baby have a stroke and how will the stroke affect my child's development? Approximately 120 Australian babies will suffer a stroke each year, based on a 1:3,500 incidence rate. This is five times higher than older children and on par with adults aged between 40-44 years.

Disease mechanisms are poorly understood and babies do not recover well, with almost 50 per cent experiencing permanent neurodevelopmental impairments affecting movement, communication, behaviour, learning and thinking.

This is an observational study aiming to recruit 50 term neonates with confirmed AIS over a three-year period from the five major tertiary NICU sites in Victoria; The Royal Children's Hospital (RCH), The Royal Women's Hospital, Mercy Hospital for Women, Monash Children’s Hospital, and Joan Kirner Women's and Children's Hospital.

• Site PI: Dr Lupe Alda 
• Status as of October 2025: Currently recruiting.

Find out more about the trial here: NIMBUS

SurPre: Surveillance of developmental delay and impairments for young children born very preterm.

Feasibility study of classifying risk of developmental problems based off 2 years old assessment. Utilising VICS 2022 cohort with control participants born outside VICs cohort. <28 weeks  <1000g

Enrolling from Growth & Development Clinic-VICS premature cohort Surveillance of developmental delay and impairments for young children born very preterm. 

1. Identify biological, medical and socio-demographic risk factors for developmental impairments in children born very preterm in a large-scale dataset generated by pooling international cohorts from an established consortium; 
2. Develop risk prediction models for developmental impairments in children born very preterm using machine learning. A digital tool for healthcare workers will then be designed based on these risk prediction models; 
3. Co-design with consumers and key stakeholders a targeted surveillance program for children born very preterm aged 2 to 4 years based on a child’s level and profile of risk; 
4. Evaluate a trial implementation of the targeted surveillance program, and then, adopting an implementation framework, we will generate an implementation toolkit for teams across Australia to use the program

• Site PI: Dr Julianne Duff
• Status as of October 2025: Currently recruiting.

Find out more about the trial here: SurPre - Centre of Research Excellence in Newborn Medicine

HUM-TE Trial

Extremely preterm babies lose water through their immature skin, causing dehydration and hypernatraemia (high blood sodium concentrations). Hypernatraemia is associated with increased mortality, cerebral bleeding, and childhood disability.

Skin water and heat loss, as well as hypernatraemia are reduced by increasing incubator humidity. However, there is worldwide variation in practice due to lack of high-quality evidence from clinical trials. Clinicians in Japan routinely initiate incubator humidity at 95% compared to 80% in Australia.

The aim of the HUM-TE study is to assess the clinical effectiveness and explore implementation contexts of 95% incubator humidity on premature infants born <27 weeks gestation during the first three days of life. 

• Site PI: Dr Katie Van Schilfgaarde

Find out more about the trial here: HUM-TE Trial 

I-HEART-U

Phase 1 Determining whether portable doppler ultrasound can be used to reliably measure the heart rate of preterm babies in the first few minutes after birth and feasibility to measure HR prior to umbilical cord clamping.
Phase 2 Assessing Heart rate with Doppler ultrasound at optimal site prior to cord clamping.

Delayed cord clamping improves preterm survival, yet 30-50% of extremely preterm newborns have their cord clamped early due to resuscitation concerns. Heart rate is the most useful marker of clinical stability but is not commonly auscultated prior to cord clamping. 

This study will determine the accuracy and precision of heart rate measured using hand-held doppler ultrasound in comparison to the reference standard (3-lead ECG) in very- and extremely- preterm newborns. To determine the feasibility of using hand-held doppler ultrasound to measure heartrate prior to umbilical cord clamping

• Site PI: Dr Shiraz Baderdeen
• Status as of October 2025: Currently recruiting.

SURFSUP Trial: Supraglottic airway surfactant for preterm infants with RDS

Respiratory distress syndrome (RDS) is a condition found commonly in babies born prematurely, which results in breathing difficulty soon after birth, due to immaturity of the lungs. Many babies will be managed successfully with breathing support alone, but some require additional treatment with surfactant. Surfactant is a liquid medicine that is given directly into the baby’s airway (wind pipe), which helps open the lungs to make breathing easier. The SURFSUP Trial will compare the new method, supraglottic airway surfactant treatment, with the current standard method, laryngoscopy. We will measure how stable babies are during surfactant treatment, including their oxygen levels and heart rate. We will also record how many babies need additional breathing support (ventilation by a breathing tube) after their surfactant treatment, to determine how effective the treatment is in helping babies with respiratory distress. If supraglottic airway surfactant treatment can be used safely and effectively, and is more comfortable and easier to use, it could become the preferred method of surfactant treatment for babies. 

• Site PI: Dr Ajit Aiyappan

Find out more about the trial here: SURFSUP Trial

The Newborn Traffic Light Tool

Some infants may spend weeks to months in the NICU, high dependency unit (HDU), and/or special care nursery (SCN), at a life stage that is critical to their neurodevelopment. 

The Newborn Traffic Light Tool© was designed as an infant advocacy tool for use during moments of pain and stress in the neonatal unit to empower the clinician to keep the infant in mind during necessary caregiving interventions. The Tool aims to increase clinician and caregiver awareness and understanding of infant behaviour during painful and stressful procedures, reminding clinicians to use well-described neurodevelopmental supports, analgesia, and other strategies to help keep infants comfortable during these procedures. The infant cues and support strategies described in the Tool are based on evidence-based neuroprotective frameworks, such as The Newborn Behavioural Assessment Scale (NBAS), The Synactive Theory of Development, and The Newborn Behavioural Observations (NBO) System. 

Does the Newborn Traffic Light Tool© fulfill its intended purpose of supporting clinicians in learning (or understanding) neuroprotective care principles and facilitating the advocacy for and implementation of such care within clinical practice?

Find out more about the research and new course here: The Newborn Traffic Light Tool

FLOW-VENT: Longer Pressure Rise Time During Mechanical Ventilation of Extremely Preterm Infants: A Randomised Crossover Trial

Gas flow determines the speed of lung motion during breathing. For preterm newborns who require breathing support it also has the potential to cause injury to the lung. Recently published pre-clinical evidence has shown that gas flows lower than currently used during respiratory support of these infants may be a major, and easily modifiable way of reducing preterm lung injury. 

The results of FLOW-VENT will inform the decision to proceed to a larger, international randomised trial, powered for longer-term respiratory outcomes (e.g. time to extubation from mechanical ventilation, bronchopulmonary dysplasia (BPD) at 36 weeks’ postmenstrual age).

• Site PI: Dr Kristin Ferguson

Find out more about the trial here: The FLOW-VENT trial