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Preterm babies may lack key vitamin at discharge, new study warns

NCT ID NCT07163962

Knowledge-focused Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study will check how common vitamin B12 deficiency is in preterm infants (born before 37 weeks) at the time they go home from the hospital. Researchers will measure B12 and related markers in blood samples from 40 babies. The goal is to understand if these vulnerable infants need extra nutritional support after discharge.

What this could mean

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

What this could lead to
If successful, this study could highlight the need for better vitamin B12 monitoring or supplementation in preterm infants after discharge.
What could go wrong
This is a small observational study (40 infants) that only measures deficiency rates, not treatment effects. Results may not apply to all preterm 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.

Participants

About 40 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2026

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.

Who is studied

Preterm infants (born \<37 weeks of gestation)

Ages

Up 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: * Gestational age at birth \<37 weeks. * Admission to one of the participating units. * Full enteral milk feeds established by suck/nasogastric tube Exclusion Criteria: * Known or suspected chromosomal, genetic or metabolic abnormalities. * Major congenital malformations * Any intercurrent condition that precludes implementation of standard feeding protocols and requires specialized formulas or changes in standard vitamin supplementation. * Any intercurrent condition that will interfere with the interpretation of results (renal impairment and hypothyroidism can lead to elevated tHcy and MMA, for example).

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Conditions

The condition(s) this trial relates to.

Premature Birth vitamin B12 deficiency vitamin deficiency disorder

As listed by the trial registrant

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

Vitamin B 12 deficiency

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

  • Norfolk and Norwich University Hospital NHS Foundation Trust

    Norwich, United Kingdom

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