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Critically IllNCT04565613

Protein Supplementation vs Standard Feeds in Underweight Critically Ill Children: A Dual-Centre Pilot RCT

A study testing Enteral protein supplementation in people with Critically Ill, run by KK Women's and Children's Hospital at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot trial is part of a long-term research program leading to a large trial to determine if a strategy of supplementing protein in a subset of critically ill children is superior to standard enteral nutrition care. Read more about this study

Who is it for?
Ages 28 days to 18 years
Conditions the study is for
Critically Ill
What is being tested?
Enteral protein supplementation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteSingapore
Study dates
25 Jan 2021to 1 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 28 days to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Between 28 days and 18 years of age
  • Have a BMI z-score < 0 on PICU admission
  • Requires respiratory support in the form of invasive or non-invasive mechanical ventilation (CPAP or BiPAP) within 24-48 hours of PICU admission, and the attending physician expects the child to require any respiratory support for at least 48 hours of PICU admission
  • Requires enteral nutrition support for feeding (e.g., oro-gastric, nasogastric, gastrostomy, naso-jejunal, oro-jejunal)
  • Have an expected PICU stay of > 48 hours

Who cannot join

  • Are not expected to survive this PICU admission because of palliative care (e.g., do-not-resuscitate status) or limited life support
  • Progressive neuromuscular disease (e.g., spinal muscular atrophy, Duchenne or other muscular dystrophy, multiple sclerosis, amyotrophic lateral sclerosis)
  • Medical conditions where increased or decreased protein intake is required, including acute kidney injury (stage 3 KDIGO criteria), chronic kidney disease (stage 4 and 5), inborn errors of metabolism, fulminant liver failure, severe burn injury
  • Contraindications to enteral nutrition (e.g., gut hemorrhage, post-gastrointestinal surgery etc.)
  • Diagnosed cow's milk protein allergy
  • Parenteral nutrition
Show all 12Show fewer
  • Premature infants who are less than corrected gestational age of 44 weeks (gestational age + weeks after birth)
  • Were previously enrolled in this trial
  • Are currently enrolled in a potentially confounding trial
  • Diagnosis of anorexia nervosa and other eating disorders
  • On extra-corporeal membrane oxygenation (ECMO) support
  • Conditions that required significant fluid restriction (≤75% of maintenance fluid) (e.g., post cardiac surgery etc.)

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National University Hospital

    Singapore, 119228

Other trials in Singapore

About this study

Official title: Protein Supplementation Versus Standard Feeds in Underweight Critically Ill Children: A Dual-Centre Randomized Controlled Pilot Trial

This pilot trial is part of a long-term research program leading to a large trial to determine if a strategy of supplementing protein in a subset of critically ill children is superior to standard enteral nutrition care. The investigators hypothesize that protein supplementation to critically ill children with body mass index (BMI) z-score <0 reduces the length of stay in the paediatric intensive care unit (PICU) and hospital, as well as the duration of mechanical ventilation (MV).

Read the detailed description

Protein malnutrition is prevalent among critically ill children and associated with poor clinical outcomes. Current guidelines for provision of protein in daily management of critically ill children in pediatric intensive care units (PICUs) are based on limited and not high-quality evidence. The current protein supplementation approach, "one-size-fits-all" nutrition prescription, may not be appropriate for every critically ill child. Given the heterogeneity of the patients admitted to the PICU, a targeted approach based on individuals' needs represents a potential advancement in PICU care.

The central hypothesis is that protein supplementation in PICU care leads to improved clinical outcomes in subgroups of patients only. The investigators propose a dual-centre pilot randomized controlled trial in Singapore with two major aims:

  1. To obtain key information for planning and conducting a large-scale multicentre study in Asia; and
  2. to evaluate the benefit of protein supplementation to critically ill children with body mass index (BMI) z-scores on PICU <0

The main clinical outcome of interest is total number of days of hospital stay (from PICU admission to hospital discharge). Two protein supplementation regimes (≥ 1.5g/kg/day vs. standard care) will be randomly allocated to PICU patients with body mass index (BMI) z-scores <0. The investigators will determine the effect of protein supplementation on total length of hospital stay and other clinical outcomes, and assess the impact of protein supplementation on acquired functional impairment of PICU survivors 6 months after hospital discharge. In addition, the investigators will explore whether muscle ultrasound is a biomarker for protein balance in pediatric critical illness.

Upon completion of this study, the investigators will have strong preliminary data to plan, refine their study approach, and execute a future large multi-centre study across Asia. These data will ultimately guide protein provision and nutritional management of patients in PICU setting.

Conditions
Critically Ill
Being tested
Enteral protein supplementation
Keywords
Critically ill, Protein supplementation, Nutrition
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enteral protein supplementationDietary supplement

    Also called Protein isolate (Nestle Beneprotein)

    The participants in the study interventional group will receive protein supplementation to reach a final goal of 1.5 g/kg/day of protein on full feeds. This will be via 100% whey protein isolate (Nestle Beneprotein). Doses will be calculated on the patient's admission weight and rounded up to the nearest 1g. Doses will not be adjusted to account for weight changes in the PICU.

    Protein supplementation will continue for a total of 7 days from the start of enrolment into the study or until PICU discharge, whichever is earlier. If the patient is able to take solid feeds during the study intervention period, the intervention will be stopped. However, if the device required for feeding is removed but the patient takes milk/liquid feeds fully, protein supplementation will continue.

Study groups in NCT04565613
Study groupRoleWhat they receive
Standard care groupNo interventionThe participants will receive feeding as per standard of care (without protein or any other supplementations).
Study interventional groupExperimentalThe participants will receive protein supplementation to reach a final goal of 1.5 g/kg/day of protein on full feeds.
Receives: Dietary Supplement: Enteral protein supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of eligible patients approached for consent

    Number of eligible patients who are approached for consent

    Measured: Throughout study period, over 36 months

  2. Proportion of participants receiving their first protein supplementation within 72 hours of enrolment

    Number of patients who received protein supplementation within 72 hours of enrolment

    Measured: Throughout the study, over 24 months

  3. Participant accrual rate

    Average monthly enrolment at each centre

    Measured: Throughout the study, over 24 months

  4. Protocol adherence

    >80% of protein target administered according to the protocol in the intervention arm

    Measured: Throughout study period, over 24 months

Secondary outcomes (7)

  1. PICU mortality

    Death in PICU

    Measured: Throughout study period, over 36 months

  2. PICU length of stay

    Duration of stay in the PICU

    Measured: Throughout study period, over 36 months

  3. Hospital length of stay

    Duration of stay in the hospital

    Measured: Throughout the study period, over 36 months

  4. Adverse events

    Development of adverse events such as feeding intolerance, diarrhoea, gastrointestinal bleeding

    Measured: Throughout study period, over 36 months

  5. Change in muscle size

    Longitudinal change in muscle size as assessed by ultrasound. Muscles for assessment include rectus femoris and diaphragm

    Measured: During PICU stay, PICU discharge, hospital discharge and 6 months follow-up

  6. Anthropometry

    Change in anthropometric measurements

    Measured: During PICU stay, PICU discharge, hospital discharge and 6 months follow-up

  7. Functional status

    Assessment of functional status via functional status scale (FSS). FSS scores ranged from 6 to 30. A higher score denotes worse outcome

    Measured: PICU admission, hospital discharge and 6 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2020
  2. Study start25 Jan 2021
  3. Primary completion1 Sep 2024
  4. Study completion1 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to enteral protein supplementation or standard care (no enteral protein supplementation) in a 1:1 ratio.
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04565613
Sponsor's protocol ID
2020/2742
Status last verified
May 2026
First submitted
15 Sep 2020
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data from this pilot study may be used for the larger study. If so, these data will not be made available to other researchers till the larger study is completed or deemed not feasible.

Publications

  • Wong JJM, Ong JSM, Ong C, Allen JC, Gandhi M, Fan L, Taylor R, Lim JKB, Poh PF, Chiou FK, Lee JH. Protein supplementation versus standard feeds in underweight critically ill children: a pilot dual-centre randomised controlled trial protocol. BMJ Open. 2022 Jan 4;12(1):e047907. doi: 10.1136/bmjopen-2020-047907.

    PubMed 34983751

Questions about this trial

What is this clinical trial studying?

A study testing Enteral protein supplementation in people with Critically Ill, run by KK Women's and Children's Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of eligible patients approached for consent (time frame: Throughout study period, over 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04565613, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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