RecruitingPhase IVInterventional

A platform trial to identify the best treatments for critically ill children admitted to paediatric intensive care

This study, called PIVOTAL, is looking for better treatments for children in paediatric intensive care units (PICUs) across the UK. Children who are critically ill often need help with breathing, heart function, or kidney support. We are testing commonly used medications and care approaches to see which are most effective and safe. This trial is designed to be flexible, meaning we can quickly learn which treatments are working best and adjust the study to focus on those, or stop others that aren't as good. This helps us find the best care sooner. The main goal is to improve the health and recovery of very sick children.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Enrolment target

12,900

Start

30 Mar 2026

Estimated completion

01 Sep 2029

Critical illness

What is this study about?

When children become very sick and need to be in an intensive care unit, doctors and nurses work hard to give them the best possible care. Sometimes, it's not always clear which treatment or medicine is the absolute best for every situation. This study, called PIVOTAL (Paediatric Intensive Care Adaptive Platform Trial), aims to find out by carefully comparing different treatments that are already being used in children's intensive care.

The usual way of testing new treatments can be slow, but this study uses a new, more flexible approach. It's like having several mini-studies running at the same time, all under one big umbrella. This means we can test many different questions and treatments quickly. A really important part of this study is that we look at the results as we go along, rather than only at the end. If a treatment is clearly working well, we can offer it to more children sooner. If a treatment isn't as helpful or causes too many problems, we can stop testing it earlier. This helps us find better ways to care for critically ill children more quickly than before.

The study starts by looking at three main areas of treatment: how sedatives like dexmedetomidine, clonidine, and midazolam are used, and other treatment areas related to how fluids are given and blood transfusion thresholds. All the treatments being looked at are ones that doctors already use regularly in children's intensive care. The overall goal is to gather strong evidence that will help doctors make even better decisions about care, ultimately improving the health and recovery of children who are critically ill.

Key takeaways

Aims to find better treatments for very sick children in intensive care.
Compares existing, common treatments, not new ones.
Uses a flexible design to find answers more quickly.
Very low additional risk as treatments are standard care.
Could improve care for future critically ill children.
Follow-up for up to 6 months after joining the study.

Who may be eligible?

This study is for children under 16 years old who are very sick and being cared for by a children's intensive care unit (PICU) or their specialist transport team. To be considered, a child needs to be born after at least 37 weeks of pregnancy (or their total age since conception is 37 weeks or more). They also need support for at least one major organ, such as help with breathing, their heart, or their kidneys, and are expected to need this support for at least another day.

Once a child meets these main criteria, doctors will then look at specific details to see if they can take part in one or more parts of the study. For example, one part might be for children who are on a breathing machine and receiving continuous calming medicine through a drip. Another part might involve looking at blood transfusions for children with certain blood levels, depending on whether they have a brain injury or are a newborn.

It's important to know that a child won't be included if they don't meet these specific health conditions. The healthcare team will carefully check all the details to make sure the study is right for your child.

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 my child under 16 years old?
Was my child born after at least 37 weeks of pregnancy (or their total age is 37 weeks or more)?
Is my child currently in a children's intensive care unit or being cared for by their transport team?
Does my child need help with breathing, their heart, or kidneys?
Is it likely my child will still need this support tomorrow?

Answer every question to see your result.

What does participation involve?

If your child is eligible and you agree for them to take part, they will be included in the study. The study looks at treatments and approaches that are already commonly used in children's intensive care. This means your child would receive care that is similar to what they would get anyway. The main difference is that the specific type or amount of a treatment might be decided by chance, like flipping a coin, from the options being studied.

Your child's doctors and nurses will continue to monitor them very closely, just as they always would in intensive care, to check for their progress and any possible side effects. The study team will follow your child's health for up to six months after they are enrolled. There are no extra visits or assessments specifically for the study that wouldn't already be part of their normal care in intensive care.

Potential risks and benefits

Because all the treatments and methods being studied are already standard practice in UK children's intensive care units, there is very little extra risk involved in taking part in this study. Doctors will monitor your child carefully for any side effects, just as they would for any patient in intensive care. While there's no guarantee that participating will directly benefit your child, the information gathered from this study will help improve care for future critically ill children. You are always free to withdraw your child from the study at any time without affecting their medical care.

Locations (24)

Addenbrooke's Hospital
Approximate
Cambridge, England
Alder Hey Children’s Hospital
Approximate
Liverpool, England
Birmingham Children's Hospital
Approximate
Birmingham, England
Bristol Royal Hospital for Children
Approximate
Bristol, England
Evelina London Children's Hospital
Approximate
London, England
Freeman Road Hospital
City only
Newcastle upon Tyne, England
Great North Children's Hospital
City only
Newcastle upon Tyne, England
Great Ormond Street Hospital for Children
Approximate
London, England
John Radcliffe Hospital
Approximate
Oxford, England
Leeds Children's Hospital
Approximate
Leeds, England
Leicester Royal Infirmary
Unverified
Leicester, England
Nottingham Children's Hospital
Unverified
Nottingham, England

Common questions

What is a 'platform trial'?

It's a modern way of doing studies that allows us to test several treatments and questions at the same time, and learn more quickly which ones are best.

Will my child receive a new or experimental drug?

No, all the treatments being studied are medicines and methods already commonly used in children's intensive care across the UK.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR), a major UK government funder of health research.

How long will the study last for my child?

The study team will follow your child's health for up to six months after they join the study.

Can I change my mind if my child is in the study?

Yes, you can withdraw your child from the study at any time without their medical care being affected.

How to find out more

Tasnin Shahid

PIVOTAL@icnarc.org +44 (0)20 45136238 Official trial record

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