Clinical Trials and Investigations

INFANT has experience of conducting international, multi-centre regulated clinical trials and clinical investigations.

See below for information on our ongoing and completed clincal trials and clinical investigations. 

Baby staring at camera

ONGOING STUDIES

ANSER

We are currently recruiting to a multicentre international Clinical Investigation of the ANSeR software system. ANSeR: The “Algorithm for Neonatal Seizure Recognition” (ANSeR) project has been funded by the Wellcome Trust under a Strategic Translational Award, in hospitals across Europe, to test a computer algorithm that can detect seizures in babies.

Around 10% of all babies delivered require admission to the special care baby unit. Some of these will have suffered a brain injury or stress. Here at INFANT, we work to provide new ways of treating these babies. Past research projects have changed the way babies at risk of fits or seizures are monitored worldwide.

Our group has helped to promote continuous EEG (electroencephalogram) recording of these babies’ brain waves so that we can detect and treat the “silent” seizures of the newborn. Neurophysiologist expertise is not available in every hospital and certainly not available 24/7. People who have the knowledge and experience to read the EEGs of a newborn are in short supply. Our multidisciplinary group of scientists, clinicians and engineers have been working for a number of years to design new equipment and computer programs that will monitor these babies, and automatically alert us if there are problems. The culmination of this work is now known as ANSeR. Our aim is to give every one of these babies an expert opinion when they need it.

ANSER Website

 

THE HIP TRIAL

HIP stands for: Management of Hypotension In the Preterm Extremely Low Gestational Age Newborn

The HIP Clinical Trial is an EU FP7 funded project that will be the largest multicentered European study in Extremely Low Gestational Age Newborns (ELGANs).

The HIP Clinical Trial addresses the FP7 Health call ‘Adapting off-patent medicines to the specific needs of paediatric populations’ by investigating whether infants born before 28 completed weeks of gestation, a restricted approach to the management of hypotension compared to using dopamine as first line inotrope within the first 72 hrs improves survival without significant brain injury at 36 weeks corrected gestational age and survival without neurodevelopmental disability at 2 years age corrected for prematurity.

HIP Trial Website

 

THE MINT TRIAL

Funded by the HRB ‘The Use of Milrinone in Neonates with Persistent Pulmonary Hypertension (PPHN) of the Newborn: (MINT 1) is a multi-centred Randomised Controlled Clinical Trial (Pilot Study) being conducted in Irish Hospitals.

Despite recent advances in the management of PPHN, the risk of mortality and adverse outcomes remains high and often prompt neonatologists to institute additional therapies. However, there is no consensus on the choice of therapies which can be added to Inhaled nitric oxide (iNO). MINT will look at intravenous milrinone used in conjunction with iNO versus iNO alone in preterm infants with a diagnosis of PPHN. The purpose of this pilot study is to assess the feasibility and to obtain preliminary data to calculate a sample size for a definitive multi-centre trial of milrinone therapy in PPHN..

COMPLETED STUDIES

NEMO

NEMO stands for: Treatment of NEonatal seizures with Medication Off-patent: evaluation of efficacy and safety of bumetanide. NEMO was an EU FP7 funded project that planned to be the largest multicentered European study of neonatal seizures and their treatment.

The aim of the NEMO study was to develop an effective antiepileptic drug regimen suitable for treatment of seizures in newborn babies using innovative strategies targeted specifically to the needs and peculiarities of babies.

NEMO Europe Website 

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