Muscle mass loss and nutrition in critically ill children

ISRCTN	ISRCTN81803039
DOI	https://doi.org/10.1186/ISRCTN81803039
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	301263
Protocol serial number	1.1, IRAS 301263, CPMS 49787
Sponsor	Alder Hey Children's NHS Foundation Trust
Funder	Research for Patient Benefit Programme

Submission date: 24/08/2021
Registration date: 08/09/2021
Last edited: 19/07/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Although children’s intensive care in the UK has improved in the last decade, for some children who stay a longer time, their recovery can be prolonged both physically and psychologically. Children on the breathing machine in intensive care can lose a lot of weight and muscle, and this slows down their recovery and can lead to longer stays both in the intensive care and in hospital. In adults in intensive care, research has shown that some of this muscle loss may be able to be lessened by giving them a higher protein feed combined with early rehabilitation in intensive care, but in children we still do not know if this weight and muscle loss is modifiable by and related to the nutrition and the amount of protein they receive. This is the aim of this study, as children are not the same as adults and frequently respond in different ways to adults. It is important to understand what happens to the child’s muscles after the child leaves intensive care and the hospital.

Who can participate?
Children (aged 0-16 years) who are admitted to the pediatric intensive care unit (PICU) and are on a breathing machine, who are expected to stay on this for more than 48 hours and who are being fed through a tube into their stomach.

What does the study involve?
If the parent/carer decides to allow their child to participate in this study, one of the researchers (who are children’s intensive care trained specialist nurses, physiotherapists, or a doctor) will get written consent form for the study. Then they will use a special ultrasound machine to look at the child’s thigh muscle (using gel and running a probe over the muscle, which does not hurt at all). They will do this measurement within 24 hours after the child is admitted to intensive care, and then on days 3, 5, 7 and 10 if the child stays that long. They will do this both when the child is asleep (sedated) and as they wake up, when they leave intensive care, when they are about to leave the hospital and 3 months later. The other information collected is about how much food (protein and calories) the child is getting and blood values can be calculated as usual from the child’s daily medical records. This will allow the researchers to see what happens to their muscles and how strong their muscles are, in addition to how much nutrition and protein they got in intensive care to see if they are related. The researchers will also look at one of their usual daily blood tests in intensive care (no extra blood will be taken) and collect information about their age and weight, why they came to intensive care and other important things that might impact on their muscles. They will also ask the child and parents some questions about their child’s activities at various time points and after 3 months (these will be the same questions each time). After 3 months (at the 3-month visit) the researchers will ask the child and or family to complete a simple (one average week) diet and activity diary for their child.

What are the possible benefits and risks of participating?
There are no additional risks to the child from being in this study. The muscle ultrasound is pain-free and completely non-invasive. The only burden to parents is the extra time required for the 3-month follow up visit, but the researchers will time this with the child’s closest follow-up hospital appointment and cover their travel and parking expenses. It is also possible to allow the child to be a part of this study and only have a brief telephone interview at 3 months (if it is not possible to come back for an extra visit). There are no benefits from being in the study.

Where is the study run from?
Alder Hey Children’s Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2020 to September 2023

Who is funding the study?
The NIHR Research for Patient Benefit (RfPB) funding stream (UK)

Who is the main contact?
Associate Prof. Lyvonne Tume
Lyvonne.Tume@edgehill.ac.uk

Contact information

Dr Lyvonne Tume
Scientific

University of Salford
Frederik Road Campus
Manchester
M6 6PU
United Kingdom

ORCID ID	0000-0002-2547-8209
Phone	+44 (0)7710421142
Email	Lyvonne.Tume@edgehill.ac.uk

Study information

Primary study design	Observational
Study design	Prospective observational single-centre study
Secondary study design	Prospective observational single-centre study
Participant information sheet	40319_PIS_V1.2_20Jul21.docx
Scientific title	A prospective observational study to explore the relationships between nuTRition, protein intake ANd muScle mass loss during and after Pediatric Intensive caRE
Study acronym	TRANSPIRE
Study objectives	To examine the relationships between muscle mass loss (measured via non-invasive ultrasound of the muscles) with nutritional intake and inflammatory markers during and after critical illness using standard, readily available bedside equipment.
Ethics approval(s)	Approved 26/07/2021, Liverpool Central Ethics Committee (address: not available; +44 (0)207 104 8197; liverpoolcentral.rec@hra.nhs.uk), REC ref: 21/NW/0192
Health condition(s) or problem(s) studied	Muscle mass loss during and after pediatric intensive care
Intervention	The researchers will use a special ultrasound machine to look at a child’s thigh muscle (using gel and running a probe over the muscle, which does not hurt at all). The researchers will do this measurement within 24 hours after the child is admitted to intensive care, and then on days 3, 5, 7 and 10 if the child stays that long. They will do this both when the child is asleep (sedated) and as they wake up, when they leave intensive care, when they are about to leave the hospital and 3 months later. The other information collected about how much food (protein and calories) the child is getting and blood values can be calculated as usual from their daily medical records. This will allow the researchers to see what happens to their muscles and how strong their muscles are, in addition to how much nutrition and protein they got in intensive care to see if they are related. The researchers will also look at one of their usual daily blood tests in intensive care (no extra blood will be taken) and collect information about their age and weight, why they came to intensive care and other important things that might impact on their muscles. They will also ask the parent some questions about their child’s activities at various time points and after 3 months (these will be the same questions each time). If the child is coming back to the hospital for any follow up, the researchers will time this 3-month measurement with their hospital visit or the parents can choose to come back at a separate time for this 3-month visit. For this 3-month visit the researchers will ask the parents and/or child to complete a simple (one average week) diet and activity diary for their child.
Intervention type	Other
Primary outcome measure(s)	1. PICU muscle wasting assessed using ultrasound at days 1, 3, 5, 7 and 10 of PICU stay, hospital discharge and 3 months 2. Protein intake during critical illness assessed using nitrogen balance (g/day) from admission to PICU discharge
Key secondary outcome measure(s)	1. Energy intake during critical illness assessed using electronic hospital records from admission to PICU discharge 2. Nitrogen balance during critical illness assessed using routine dietician calculations from admission to PICU discharge 3. Inflammatory markers (CRP) that relate to the severity of illness, measured using routinely collected blood tests over the PICU stay 4. Muscle wasting and function changes assessed using ultrasound during PICU admission and from PICU discharge to 3 months after PICU discharge 5. Risk factors for PICU-muscle wasting assessed using history and electronic hospital records during PICU stay 6. Length of ventilation, PICU length of stay, and hospital length of stay assessed using electronic hospital records at PICU and hospital discharge 7. Functional physical state (FSS) assessed using FSS score at PICU and hospital discharge and at 3 months 8. Muscle function recovery assessed using Bayley’s motor score, MFM 20 or MFM 32 at PICU and hospital discharge and at 3 months 9. Quality of life assessed using PedsQL at 3 months after PICU discharge
Completion date	30/09/2023

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	0 Years
Upper age limit	16 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Invasively ventilated children (term neonate to 16 years) 2. Expected to stay >48 hours in PICU 3. Receiving some form of nutrition (enteral and/or parenteral) 4. Parents consent to the study 5. Normal neurologically 6. Of walking age 7. Independently ambulatory pre-admission 8. No previous PICU admission within the last 5 years 9. No known neuromuscular disease
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	11/10/2021
Date of final enrolment	31/07/2023

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Alder Hey Children's Hospital

East Prescott Road
Liverpool
L12 2AP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Lyvonne Tume (Lyvonne.Tume@edgehill.ac.uk).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		30/03/2024	19/07/2024	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	version 1.2	20/07/2021	24/08/2021	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 1	07/05/2021	24/08/2021	No	No

Additional files

40319_PIS_V1.2_20Jul21.docx: Participant information sheet
40319_PROTOCOL_V1_07May21.docx: Protocol file

Editorial Notes

19/07/2024: Publication reference added.
30/11/2023: The contact email was updated.
05/10/2021: The recruitment start date has been changed from 01/10/2021 to 11/10/2021.
01/10/2021: The CPMS number was added to the protocol/serial no. field.
24/08/2021: Trial's existence confirmed by the HRA and Health and Care Research Wales (HCRW).