RecruitingPhase IInterventional

A study to test the safety of a new melatonin treatment for babies with brain injury receiving cooling therapy

The ACUMEN study is looking at a new way to help babies born with a brain injury called HIE. This injury happens when a baby doesn't get enough oxygen and blood to their brain around birth. Cooling therapy is the usual treatment, but some babies still face challenges later on. This study is testing if a natural substance called melatonin, given through a drip, can safely protect the baby's brain cells. Researchers want to know if giving melatonin alongside cooling therapy can help these babies have better health and development as they grow. It's a first step to see if this treatment might work.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

The Comprehensive Clinical Trials Unit at University College London

Enrolment target

Start

30 Apr 2025

Estimated completion

30 Nov 2026

Moderate to severe hypoxic-ischaemic encephalopathy (HIE) in newborn infants

What is this study about?

The ACUMEN study is a research project focused on improving how we treat newborn babies who have had a brain injury called HIE. This injury occurs when a baby's brain doesn't receive enough oxygen and blood flow, usually around the time of birth. While there's a standard treatment called cooling therapy (where the baby's body temperature is gently lowered), many babies with HIE can still experience long-term problems, such as delays in their development or learning difficulties.

This study is testing a new treatment using melatonin. Melatonin is a natural hormone that our bodies make, and it has shown promise in laboratory studies for protecting brain cells. In this study, melatonin will be given to babies through a drip into their vein. The main goal is to check if this melatonin treatment is safe for babies and if it can reach the right levels in their blood without causing problems. If it proves to be safe and effective, it could potentially be used in future larger studies to help more babies with HIE.

Babies taking part will receive melatonin alongside their usual cooling therapy. They will be carefully watched in the hospital for 72 hours, and healthcare professionals will monitor everything closely. Researchers will collect blood samples, take special brain scans (like MRI), and monitor brain activity to understand how the treatment works and what effect it has. The hope is that this research will pave the way for better treatments that can improve the long-term health and development of babies affected by HIE.

Key takeaways

New study for babies with brain injury (HIE) receiving cooling.
Testing if melatonin, a natural hormone, can safely protect baby's brain.
Melatonin given through a drip over 3 days.
Babies will have extra, detailed monitoring in hospital.
Aims to improve long-term development for babies with HIE.
Your decision to join is completely voluntary and will not affect care.

Who may be eligible?

This study is for newborn babies who have been diagnosed with a moderate to severe brain injury called HIE and are already receiving cooling therapy. Babies must be born at 36 weeks gestation or later (meaning they weren't very premature) and be in a stable condition when they start the treatment.

There are also some important checks to make sure your baby is suitable. For instance, they need to have special monitoring in place, and their blood pressure needs to be stable. If they are having seizures, these need to be controlled with medication before the study drug is given. We also sadly cannot include babies who are very unwell, such as those needing the highest level of intensive care or those who are considered too sick to safely take part in a new treatment study.

Babies cannot be older than 6 hours when the study drug is planned to be given. Your medical team will talk through all these points with you in detail to see if your baby might be able to join the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your baby diagnosed with moderate to severe HIE?
Is your baby already undergoing cooling therapy?
Was your baby born at 36 weeks or later?
Is your baby in a stable condition as assessed by the doctors?
Is your baby less than 6 hours old when treatment would start?
Do you consent for your baby to take part?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will receive the melatonin treatment alongside their standard cooling therapy. The melatonin will be given through a drip into a vein. This treatment will happen over 3 days (72 hours), with six doses in total. Your baby will be in the Neonatal Intensive Care Unit (NICU) and will be very closely monitored throughout this time, and for the rest of their hospital stay.

Taking part involves several assessments. This includes regular blood samples (kept within safe limits) to check how well the melatonin is working and for other important markers. Your baby will also have their brain activity monitored continuously with special sensors placed on their head, and they may have brain scans (like an MRI). These procedures are designed to be as comfortable and stress-free as possible for your baby. All of these tests help the researchers understand how the melatonin is affecting your baby and if it is safe and potentially helpful.

Potential risks and benefits

Taking part in this study offers potential benefits, such as receiving a new treatment (melatonin) that could help protect your baby's brain beyond standard care. Babies in the study will also receive extra detailed monitoring, like continuous brain activity checks and close observation of brain oxygen levels, which may help identify and address issues sooner. However, there are also potential risks, though measures are in place to reduce them significantly. These include a very small chance of allergic reactions, careful monitoring of a small amount of alcohol in the melatonin liquid, and close watch for changes in blood pressure. Blood sampling, brain activity monitoring, and MRI scans are routine procedures, but they can cause mild discomfort. You are completely free to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (10)

Uclh
Approximate
London, United Kingdom
The Royal London Hospital
Approximate
London, United Kingdom
St Mary's Hospital
Approximate
Manchester, United Kingdom
Royal Infirmary of Edinburgh at Little France
City only
Lothian, United Kingdom
Liverpool Womens Hospital
City only
Liverpool, United Kingdom
Cork Maternity Hospital
Approximate
Cork, Ireland
Coombe Hospital
Approximate
Dublin, Ireland
Rotunda Hospital
Approximate
Dublin, Ireland
Flinders Medical Centre
Approximate
Bedford Park, Australia
Monash Children’s Hospital
Approximate
Clayton, Australia

Common questions

What is HIE?

HIE is a type of brain injury in newborns that happens when the brain doesn't get enough oxygen and blood around the time of birth.

What is melatonin?

Melatonin is a natural hormone that our bodies make. In this study, it's being tested as a medicine to protect brain cells.

Will my baby still get their usual cooling therapy?

Yes, babies in this study will receive the melatonin treatment alongside their standard cooling therapy and all other routine care they need.

How long will my baby be in the study?

The melatonin treatment is given over 3 days (72 hours). Your baby will be closely monitored throughout their hospital stay.

Can I take my baby out of the study at any time?

Yes, you have the right to withdraw your baby from the study at any point, and it will not affect their medical care.

How to find out more

Felicia Ikeji

cctu.acumen@ucl.ac.uk +44 (0)20 3108 4255 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.