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New screening tool could help preterm toddlers worldwide

NCT ID NCT05065385

Knowledge-focused Sponsor: Giancarlo Natalucci 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a new, low-cost test called the INTER-NDA can effectively screen for developmental delays in 2-year-old children who were born preterm. Researchers will assess 800 children in Switzerland to see if this tool can be used more widely, especially in places with limited resources. The goal is to catch problems early so children can get the support they need.

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 800 people

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

Started

Mar 2022

Expected to finish

Dec 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

All preterm born infants (i.e. born at \< 37 weeks' gestation) who were either born at or received neonatal care at the University Hospital Zurich in 2019-2021 are eligible for the present study.

Ages

18 to 30 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Former patient of the Department of Neonatology of the University Hospital Zurich * Born between 01.01.2019 and 31.12.2021, i.e. aged 18 to 30 months at the time of the research visit * Gestational age below 370/7 weeks * Parent consent Exclusion Criteria: * Genetically defined syndrome (including chromosomal aberration) or inborn error of metabolism adversely influencing life expectancy or neurodevelopment. * Major congenital malformations requiring surgical correction or potentially affecting neurodevelopmental outcome. * Hypoxic ischemic encephalopathy after perinatal asphyxia defined as grade 2 or 3 according to Sarnat and Sarnat\[19\]. * Neonatal drug withdrawal syndrome or known maternal substance consumption of following illicit drugs during pregnancy: cocaine, heroin, Lysergic acid diethylamide (LSD), 3,4-Methylenedioxymethamphetamine (ecstasy), phencyclidine (PCP), and other amphetamine/methamphetamine. * Children of parents who are not speaking German

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Prematurity

Contacts and locations

Locations

  • Department of Neonatology

    Zurich, Canton of Zurich, 8091, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.