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Can extra protein help sick kids leave the ICU sooner?

NCT ID NCT04565613

Knowledge-focused Sponsor: KK Women's and Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding extra protein to standard feeding helps underweight critically ill children recover faster. Researchers enrolled 34 children aged 28 days to 18 years who were on breathing support in the intensive care unit (PICU). The goal was to see if this approach is practical and safe, and to gather data for a larger future trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

34 people

The number who actually took part.

Started

Jan 2021

Finished

Mar 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

28 days to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Between 28 days and 18 years of age 2. Have a BMI z-score \< 0 on PICU admission 3. 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 4. Requires enteral nutrition support for feeding (e.g., oro-gastric, nasogastric, gastrostomy, naso-jejunal, oro-jejunal) 5. Have an expected PICU stay of \> 48 hours Exclusion Criteria: 1. Are not expected to survive this PICU admission because of palliative care (e.g., do-not-resuscitate status) or limited life support 2. Progressive neuromuscular disease (e.g., spinal muscular atrophy, Duchenne or other muscular dystrophy, multiple sclerosis, amyotrophic lateral sclerosis) 3. 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 4. Contraindications to enteral nutrition (e.g., gut hemorrhage, post-gastrointestinal surgery etc.) 5. Diagnosed cow's milk protein allergy 6. Parenteral nutrition 7. Premature infants who are less than corrected gestational age of 44 weeks (gestational age + weeks after birth) 8. Were previously enrolled in this trial 9. Are currently enrolled in a potentially confounding trial 10. Diagnosis of anorexia nervosa and other eating disorders 11. On extra-corporeal membrane oxygenation (ECMO) support 12. Conditions that required significant fluid restriction (≤75% of maintenance fluid) (e.g., post cardiac surgery etc.)

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Conditions

The condition(s) this trial relates to.

Critical Illness

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critically ill

Contacts and locations

Locations

  • National University Hospital

    Singapore, 119228, Singapore

More trials for these conditions

Other studies related to the condition(s) this trial covers.