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Study aims to Fine-Tune IV nutrition for preemies

NCT ID NCT06372314

Knowledge-focused Sponsor: The Hospital for Sick Children Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how much of four essential amino acids (isoleucine, leucine, valine, and tryptophan) premature babies need when they get nutrition through an IV. Researchers will test about 80 stable newborns in Brazil to see if current commercial formulas provide too much of these amino acids. The goal is to improve feeding solutions for these vulnerable 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

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

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

1 day to 28 days

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. Stable preterm babies that are growing and fully TPN fed (at least 90% of calories and protein). 2. TPN providing adequate calories and protein as determined by attending physician and dietitian. 3. Babies born ≥ 28 weeks gestation, 4. ≤ 28 days chronological age at the time of the study, 5. Birth weight and length appropriate for gestational age, 6. Medically stable as determined by normal blood results and lack of a fever or infection, 7. At least 3 days after surgery, if the baby had a surgery Exclusion Criteria: 1. Babies on mechanical ventilation, on low flow oxygen and CPAP. 2. Small for gestational age, 3. On medications known to affect protein and amino acid metabolism, 4. Documented infection, fever 5. Unstable medical condition 6. Receiving enteral feeding providing \> 10% of protein intake

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Conditions

The condition(s) this trial relates to.

Hyperphagia

As listed by the trial registrant

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

Neonates managed in the icu Neonates on TPN Stable neonates Stable neonates receiving total parenteral nutrition (TPN) To analyze samples from A study conducted in brazil

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil

    RECRUITING

    Santa Maria, Brazil