RecruitingNAINTERVENTIONAL

Continuous vs Bolus Protein (Protein Regimen Outcomes) in Critically Ill Children (Kids In Distress)

This study, called 'Kids In Distress,' is looking at how best to give protein to children aged 1 to 11 who are seriously ill in hospital. When children are very sick, it's important to make sure they get enough nutrients, especially protein, to help them recover and keep their strength. Researchers are comparing two different ways of giving protein through a feeding tube: a continuous, slow drip, or bigger, regular doses (called a bolus). The main aim is to find out if one method is better at helping children maintain their weight and muscle mass during their time in intensive care. They will also check if giving protein in bigger, regular doses helps children get more protein overall.

At a glance

Status

Recruiting

Phase

Sponsor

University of British Columbia

Enrolment target

Start

13 Feb 2024

Estimated completion

12 Dec 2027

Critical Illness Pediatric Intensive Care Enteral Nutrition Therapy Dietary Protein

What is this study about?

When children are seriously ill and in intensive care, it's really important they get the right nutrition. Protein, in particular, is vital for their growth, healing, and keeping their muscles strong. This study, nicknamed 'Kids In Distress,' is trying to figure out the best way to give these important proteins to children aged 1 to 11.

Imagine a special feed that goes into your child's tummy through a tube. This study is comparing two ways of giving the protein part of this feed. One way is a 'continuous' method, which is like a slow, steady drip, giving a little bit of protein all the time. The other way is 'bolus' delivery, which means giving bigger amounts of protein at certain times throughout the day, like a meal.

The main goal of this research is to see if one of these methods is better at helping sick children keep their weight and muscle. They will look at things like changes in arm measurements and muscle scans to find this out. They also want to know if giving protein in bigger, regular doses helps children get more protein into their bodies each day, which could be very helpful for their recovery.

Key takeaways

Study for very sick children (1-11 years) in intensive care.
Compares two ways of giving protein through a feeding tube.
Aims to see which method helps children keep muscle and weight.
Involves arm measurements and harmless muscle scans (ultrasound).
Participation will not change their regular medical care.
Your decision to join or not will not affect your child's treatment.

Who may be eligible?

This study is particularly for children who are aged between 1 and 11 years old. They need to be in a children's intensive care unit and are expected to stay there for at least three days. Also, they must be getting their nutrition through a feeding tube that goes directly into their stomach.

However, some children might not be suitable for this study. For example, if a child has certain muscle conditions like muscular dystrophy, or if they are already on high doses of certain powerful medicines or hormones. Children who can't have feeding tubes, or whose feeding tube goes into a different part of their digestion (like the small bowel), also can't join.

Finally, if a child needs a very special diet for conditions like severe burns or certain metabolic illnesses, or if they have an allergy to cow's milk protein and the study protein contains it, they won't be able to take part.

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 child aged between 1 and 11 years old?
Is your child currently in a children's intensive care unit?
Is your child expected to stay in intensive care for at least 3 days?
Is your child receiving their food through a feeding tube that goes into their stomach?
Does your child have any muscle conditions, like muscular dystrophy?
Does your child need a very specialised diet or have a severe cow's milk allergy?

Answer every question to see your result.

What does participation involve?

If your child is eligible and you agree for them to take part, the first step is to get some measurements. Within three days of being admitted, trained staff will gently measure your child's weight, their arm size, and use a special scanner (like an ultrasound, similar to what's used during pregnancy) to look at the muscle in their upper thigh. These measurements are simple and don't hurt.

After these initial checks, your child will be put into one of two groups: one where they receive protein continuously, or one where they get it in bigger, regular doses. This is a bit like flipping a coin, so it's decided by chance. For the next two weeks, the research team will keep a close eye on how much nutrition your child is getting each day.

On day 3, day 5, day 7, and day 14 after starting the protein, your child will have their arm measured and their thigh muscle scanned again. This helps the researchers see if there are any changes over time. Your child will continue to receive their standard medical care throughout the study.

Potential risks and benefits

Taking part in this study could potentially help us understand the best way to support very sick children with their nutrition, which might improve their recovery in the future. There are no known direct risks to your child from the extra measurements (arm circumference and ultrasound scans) as they are quick and painless. The way protein is given will be carefully monitored by the medical team. You also have the right to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

BC Childrens Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is the main goal of this study?

To find out if giving protein continuously or in bigger, regular doses is better for helping very sick children keep their weight and muscle.

Which children can take part?

Children aged 1 to 11 in intensive care, who are expected to stay at least 3 days and are fed through a tube into their stomach.

What will my child have to do if they join?

They'll have their weight, arm size, and thigh muscle measured with an ultrasound at the start, and then arm and muscle measurements again on days 3, 5, 7, and 14.

Will my child's medical care change?

No, your child will continue to receive the best standard medical care they need while in intensive care, regardless of whether they join the study.

Can I change my mind about my child participating?

Yes, you can choose to remove your child from the study at any time, and this will not affect their medical care in any way.

How to find out more

Kaitlin A Berris, BSc

kaitlin.berris@bcchr.ca 604-875-2000 Official trial record

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