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Can cutting protein save critically ill newborns?

NCT ID NCT07801040

Disease control Sponsor: Indonesia University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This trial tests whether giving critically ill newborns less protein during the acute phase of their illness can improve outcomes. Researchers will compare a reduced protein intake of 1.2 grams per kilogram per day against the standard protein regimen used in local guidelines. The study includes 52 infants over 32 weeks postmenstrual age and weighing more than 1,500 grams. The main goal is to see if protein restriction lowers the 7-day death rate and helps infants recover from the acute phase faster.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Amino acid infusion with reduced protein (1.2 gram/kg/day)
What this could lead to
If it works, this could point toward safer nutrition strategies for critically ill newborns, potentially reducing early deaths and speeding recovery.
What could go wrong
This is a small, early study with only 52 participants, so results may not apply broadly. Restricting protein could also risk inadequate nutrition for growing infants.

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

52 people

The number who actually took part.

Started

Oct 2025

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

72 hours to 1 month

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: * postmenstrual age \>32 weeks old * actual weight \>1.500 gram Exclusion Criteria: * given \<1 gram/kg/day of protein * critical congenital malformation

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Conditions

The condition(s) this trial relates to.

Critical Illness Hyperphagia

As listed by the trial registrant

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

Critical illness Parenteral nutrition

Contacts and locations

Locations

  • Ciptomangunkusumo Public Hospital

    Jakarta Pusat, DKI Jakarta, 12810, Indonesia

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