RecruitingOBSERVATIONAL

Rebooting Infant Pain Assessment: Using Machine Learning to Exponentially Improve Neonatal Intensive Care Unit Practice

This important study aims to improve how we understand and manage pain in premature babies in Neonatal Intensive Care Units (NICU). A team of experts from different countries is developing a clever computer program, called a machine learning algorithm, to help tell the difference between different types of discomfort in premature infants. For example, it will help work out if a baby is in pain or is just generally unsettled. They will do this by observing how babies react during a common, routine procedure (a heel lance to get a blood sample). By carefully watching facial expressions, heart rate, oxygen levels, and brain activity, the program will learn to recognise unique signs of pain. The goal is to give healthcare professionals a better tool to quickly and accurately assess and treat pain in these vulnerable babies.

At a glance

Status

Recruiting

Sponsor

York University

Enrolment target

400

Start

01 Nov 2020

Estimated completion

01 Dec 2026

Acute Pain

What is this study about?

When newborn babies, especially those born early, are in hospital, they might go through procedures that can cause discomfort or pain. Because these tiny babies can't tell us what's wrong, it can be really challenging for doctors and nurses to know if they are in pain or just generally upset. If pain isn't managed well, it can have lasting effects on a baby's health and development.

This study brings together a group of international experts, including doctors, scientists, and engineers. They are working together to create a smart computer program, like a super-smart assistant. This program will learn to recognise the subtle differences between a baby being in pain and them being distressed for other reasons, such as being hungry or tired. This will be a significant step forward in ensuring premature babies receive the best possible care for their comfort.

The team will observe 400 premature babies during a routine heel lance, which is a small prick to get a blood sample. They will look at different things like the baby's facial expressions, heart rate, how much oxygen is in their blood, and their brain activity. By collecting all this information, the computer program will learn to spot the unique patterns that show when a baby is in pain versus when they are experiencing other types of distress. This will help healthcare professionals respond more accurately and quickly to their needs.

Key takeaways

Aims to improve pain detection in premature babies.
Uses smart computer programs to learn from baby reactions.
Observes babies during a routine heel prick (heel lance).
Looks at facial expressions, heart rate, oxygen, and brain activity.
No extra procedures for participating babies.
Helps develop better tools for future pain management in NICUs.

Who may be eligible?

This study is looking for two main groups of people to take part. Firstly, they want to talk to parents who currently have a child in the NICU, or healthcare professionals who work in the NICU. For this part, you need to be able to speak English fluently.

Secondly, they are looking for specific premature babies to participate. These are babies born between 28 and nearly 33 weeks of pregnancy, and who are less than six weeks old after birth. They also need to be having a routine heel lance procedure as part of their care.

Babies would not be able to join the study if they have certain health conditions like birth defects, or if they are already receiving strong pain relief or calming medicines (though sugar water, often used for comfort, is allowed). Babies with skin irritations like a nappy rash would also not be able to take part.

Quick self-check

Are you a parent with a child currently in NICU, or a NICU healthcare professional?
Can you communicate fluently in English?
Is your baby born between 28 and nearly 33 weeks of pregnancy?
Is your baby less than 6 weeks old?
Is your baby having a routine heel lance soon?
Does your baby have any birth defects or is taking strong pain relievers other than sugar water?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your baby is eligible and you agree to take part, the researchers will observe your baby during a routine heel lance procedure that they would be having anyway. This means there are no extra pokes or prods for your baby. They will record things like your baby's facial expressions using video, and attach small sensors to monitor their heart rate, oxygen levels, and brain activity (EEG). These are all non-invasive and generally well-tolerated. The study measurements will take place during this single routine procedure and will likely last a short period, probably no longer than an hour or so, including preparation time. You, as the parent, might also be asked to share your thoughts and experiences in an interview.

Potential risks and benefits

Taking part in this study could help improve pain management for premature babies in the future, not just for your child but for many others. While the information gathered may not directly change your baby's immediate care, it contributes valuable knowledge. The risks to your baby are very low, as the study only involves observations and measurements during a procedure they would already be having. The sensors used are gentle and non-invasive. You have the right to change your mind and withdraw from the study at any time, without it affecting your or your baby's medical care.

Locations (2)

Mount Sinai Hospital
Toronto, Canada· Recruiting
University College London Hospital
London, United Kingdom· Recruiting

Common questions

What is a 'heel lance'?

A heel lance is a very common, quick procedure where a baby's heel is pricked to get a small blood sample for essential tests. It's done routinely in NICUs.

What is 'machine learning'?

Machine learning is when computers are taught to learn from information, similar to how people learn from experience. In this study, the computer will learn to recognise patterns of pain in babies.

Will my baby get extra tests or procedures for this study?

No, your baby will only be observed during a heel lance procedure they are already having as part of their routine medical care. No additional invasive tests are involved.

How will this study help my baby?

While the results won't immediately change your baby's care in this specific instance, the study's goal is to create better tools for doctors and nurses to understand and treat pain in premature babies in the future, ultimately benefiting many infants.

What if I change my mind about my baby participating?

You are completely free to withdraw your consent for your baby to participate at any time, without needing to give a reason. This will not affect your baby's medical care in any way.

How to find out more

Rebecca Pillai Riddell, PhD

rpr@yorku.ca 416736200 Official trial record

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