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Could a thyroid boost help tiny preemies grow smarter and stronger?

NCT ID NCT07625722

Disease control Sponsor: Shandong Provincial 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial investigates whether giving a thyroid hormone (levothyroxine) to very small preterm infants with mildly low thyroid function can improve their physical growth and brain development by age two. The study includes infants born weighing under 1500 grams who are small for their gestational age. Researchers will compare those who receive the hormone with those who do not, tracking height, weight, head size, and thinking skills.

What this could mean

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

Active substance
levothyroxine (thyroid hormone)
What this could lead to
If it works, this could point toward a simple treatment to improve growth and brain development in vulnerable preterm infants.
What could go wrong
This is a small, early-stage trial, so results may not apply broadly. The hormone dose must be carefully adjusted to avoid side effects.

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 106 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

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

2 to 2 weeks

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: * Preterm infants born Small for Gestational Age (SGA) with a birth weight \< 1500g； * Admitted to a participating Neonatal Intensive Care Unit (NICU) within 7 days of birth； * Serum concentrations of TSH, FT4, and FT3 are measured weekly during the first and second weeks of life，any single TSH measurement during this period is between 6 and 20 mIU/mL； * Written informed consent obtained from the parents. Exclusion Criteria: * Diagnosis of Congenital Hypothyroidism (CH) with serum TSH \> 20 mIU/mL within the first 2 weeks of life and receiving L-T4 treatment; * Persistent serum TSH \< 6 mIU/mL throughout the first 2 weeks; * Elevated thyroid hormone levels(T3, T4, FT3, or FT4) above the reference range within the first 2 weeks; * Diagnosis of Grade III or IV Intraventricular Hemorrhage (IVH) within the first 2 weeks of life; * Presence of major congenital malformations of vital organs or known chromosomal/genetic disorders; * History of maternal thyroid disease or maternal use of thyroid-related medications.

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Conditions

The condition(s) this trial relates to.

fetal growth restriction neurodevelopmental disorder Premature Birth

As listed by the trial registrant

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

Neurodevelopment outcome Preterm Sga and growth Thyroid function

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

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250021, China

More trials for these conditions

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