RecruitingNAINTERVENTIONAL

Phenylalanine, Methionine and Histidine Requirements in TPN Fed Neonates

This study focuses on newborn babies who are receiving all their food through a drip, called Total Parenteral Nutrition (TPN). Researchers want to find out the exact amount of three vital building blocks of the body, called amino acids (phenylalanine, methionine, and histidine), that these babies really need. Currently, they believe the amounts in standard TPN solutions might be higher than necessary. By giving babies different amounts of these amino acids and collecting breath and urine samples, the study aims to accurately measure how the babies use them. This research could help improve TPN solutions so babies get just the right nutrition for healthy growth.

At a glance

Status

Recruiting

Phase

Sponsor

The Hospital for Sick Children

Enrolment target

Start

02 Apr 2023

Estimated completion

02 Sep 2027

Stable Neonates Receiving Total Parenteral Nutrition (TPN)

What is this study about?

This study is investigating something very important for newborn babies who need to be fed through a special drip, known as Total Parenteral Nutrition (TPN). TPN delivers all the necessary nutrients directly into the baby's bloodstream, often because their digestive system isn't ready to handle food yet. We're particularly interested in three essential protein building blocks, called amino acids: phenylalanine, methionine, and histidine. These are crucial for a baby's healthy growth and development.

Currently, the standard TPN solutions contain certain amounts of these amino acids. However, the doctors and researchers involved in this study believe that babies might actually need less of these specific amino acids than what is currently provided. If they can find out the exact right amount, it could help make TPN even better and ensure babies receive optimal nutrition without any unnecessary components.

To do this, the study uses a special method that involves looking at a baby's breath and urine. By giving tiny, safe amounts of these amino acids with special labels, researchers can trace how the baby's body uses them. This helps them work out the ideal intake. The findings from this research could lead to updated guidelines for feeding premature and sick newborns, helping them grow stronger and healthier.

Key takeaways

The study aims to find the right amount of three key nutrients (amino acids) for babies on TPN.
Researchers think current TPN might provide more of these nutrients than needed.
Breath and urine samples will help understand how babies use these nutrients.
This research could improve TPN solutions for premature and sick newborns.
Participation involves minor additional monitoring and no direct changes to your baby's care.

Who may be eligible?

This study is looking for stable newborn babies who are receiving all their nutrition through a drip (Total Parenteral Nutrition, or TPN). This means they are getting enough calories and protein to grow well, as decided by their doctors and dietitians.

Babies can join if they were born at 28 weeks of pregnancy or later, and are no more than 28 days old when the study starts. They should have been a healthy size and length when they were born. It's also important that they are generally feeling well, with normal blood test results, no fever, and no signs of infection. If a baby has had surgery, they must be at least three days past their operation and recovering well.

However, some babies cannot take part. This includes those who need breathing support like a breathing machine (ventilator), low flow oxygen, or CPAP. Babies who were very small for their gestational age when born, or are taking medicines that affect how their body uses proteins, cannot join. Those with an active infection, fever, or any unstable medical condition are also not eligible, nor are babies who are getting more than 10% of their protein through regular feeding.

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 only receiving food through a TPN drip (not much by mouth)?
Was your baby born at 28 weeks of pregnancy or later?
Is your baby currently less than 28 days old?
Is your baby generally well and stable, with no fever or signs of infection?
Is your baby not on breathing support like a breathing machine or CPAP?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will receive different amounts of the amino acids being studied as part of their regular TPN drip. Each different amount will be given over a two-day period.

On the first day, your baby will receive their usual TPN. On the second day, the TPN will be slightly adjusted to have a different amount of the amino acid being investigated. To understand how your baby uses these amino acids, a very tiny, safe amount of a specially labelled amino acid will be added to the drip.

During these two days, samples of your baby's breath and urine will be collected. These samples will help the researchers see how the labelled amino acid is processed by the body. About twice, a very small blood sample (less than a quarter of a teaspoon) will also be taken. The researchers will try to do this at the same time as any routine blood tests that your baby needs for their clinical care, to avoid extra pokes. The total duration of your baby's involvement will depend on which amino acid study they participate in, as each baby may receive one or two different levels of the amino acid being tested.

Potential risks and benefits

Taking part in this study might help researchers understand more about the specific nutritional needs of babies receiving TPN, which could lead to better care for similar babies in the future. There are no direct benefits to your baby from taking part. The risks are very small; the special labelled amino acid added to the drip is given in tiny, safe amounts, and the blood samples will be coordinated with routine tests to minimise 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 (1)

Glenda Courtney-Martin
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is TPN?

TPN stands for Total Parenteral Nutrition. It's a way of giving all the nutrients a baby needs directly into their bloodstream through a special drip, usually when they can't feed normally.

What are amino acids?

Amino acids are essential building blocks that our bodies, including babies' bodies, need to grow, repair tissues, and carry out many important functions.

Will my baby get extra needle pokes?

The researchers will try to collect blood samples at the same time as any routine blood tests your baby already needs, to avoid extra pokes as much as possible.

How long will my baby be in the study?

Your baby will be involved for two days for each level of amino acid being tested. This study plans to test one or two levels per baby.

What is the Carbon Oxidation method?

It's a clever way researchers measure how your baby's body uses and processes the amino acids by looking at their breath and urine samples.

How to find out more

Glenda Courtney-Martin

glenda.courtney-martin@sickkids.ca 4168135744 Official trial record

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