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Pandemic babies: did lockdowns shape preterm infant brains?

NCT ID NCT07569523

Knowledge-focused Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 120 preterm infants born before 34 weeks to see if those born during the COVID-19 pandemic (2020-2021) develop differently than those born after (2023-2024). Researchers will test thinking, movement, and language skills using play-based assessments. The goal is to understand how pandemic-related changes may have impacted early development.

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 reveal whether the pandemic environment affected early brain development in preterm babies, guiding future care.
What could go wrong
This is an observational study, not a treatment trial. Results may show no clear differences, and findings may not apply to other hospitals or regions.

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 120 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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 before 34 weeks of gestation), born from March 2020 to December 2021 (case group) and preterm infants (born before 34 weeks of gestation), born from January 2023 to December 2024 (control group). All those who have entered the NICU of Hospital de Sant Pau and follow up in external consultations.

Ages

Up to 5 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: * Preterm babies (\<34 weeks of gestation) born between March 2020 and December 2021 for case group). * Preterm babies (\<34 weeks of gestation) born between January 2023 to December 2024 (control group). * Babies who were admitted to the NICU of the Hospital de Sant Pau. * Babies who were followed up in External Consultations of the same hospital at least until their first year of age. Exclusion Criteria: * Preterm infants ≥34 weeks or preterm born outside the periods described in the inclusion criteria. * Concurrent diagnosis of genetic pathology or major malformations. * Families who discontinued follow-up or did not attend scheduled appointments.

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

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

COVID-19 Preterm infant development

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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