PrematurityEveryPremNCT05065385
The EveryPrem Project: Evaluating the INTER-NDA for Standardized Neurodevelopmental Screening at 2 Years of Age for Children Born Preterm.
An observational study of Prematurity, run by Giancarlo Natalucci at 1 site in Switzerland.
Trial summary
Neurodevelopmental follow-up of infants at high-risk such as preterm born is necessary in order to early detect impairments and early start a supportive/therapeutic intervention. Valid tools should be available for screening infants with developmental problems even where resources are limited. Read more about this study
- Who is it for?
- Ages 18 to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- What is being tested?
- INTER-NDA
- How many people
- 800 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neonatology
Zurich, Canton of Zurich, 8091
About this study
Neurodevelopmental follow-up of infants at high-risk such as preterm born is necessary in order to early detect impairments and early start a supportive/therapeutic intervention. Valid tools should be available for screening infants with developmental problems even where resources are limited. Such screening would ensure an adequate medical care during and after hospital discharge as well as evidence-based parental pre- and postnatal counselling. While in Switzerland, these tools are specifically needed for the neurodevelopmental surveillance of moderate to late pretem born infants, in low- and mid-income countries, they are needed to monitor the whole population of preterm born infants.
To fill this important gap, the present study aims to determine whether it is feasible to extend neurodevelopmental screening (currently offered to only a very small part of children born preterm), by using a new cost-effective neurodevelopmental assessment, the INTERGROWTH-21st Neurodevelopment Assessment (INTER-NDA, www.inter-nda.com Assessment) at age 2 years.
Read the detailed description
The pirmary objectives of the study are:
- In very preterm born infants (born < 32 weeks' gestation)
- To assess the concurrent validity of the INTER-NDA with the Bayley-III[13] at 2 years of corrected age in VPT infants.
- In moderate to late preterm infants (born between 32 and 36 weeks' gestation) - To screen neurodevelopment performances at corrected 2 years of corrected age in MLPT infants by means of the INTER-NDA and to compare values with international INTER-NDA standard values.
- Conditions
- Prematurity
- Being tested
- INTER-NDA
- Keywords
- Prematurity, Neurodevelopement, Follow-up, Screening, INTER-NDA
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTER-NDADiagnostic test
Also called Bayley Scales of Infant and Toddler Development, 3rd Edition
Neurodevelopmental Screening Test at age 2 years.
What is being measured
The primary outcome is the main question the study is designed to answer.
INTER-NDA domain scores and centiles
The INTERGROWTH-21st Neurodevelopment Assessment (INTER-NDA) is new cost-effective neurodevelopmental assessment for 2-year old infants.
Measured: At age 18 to 20 months; test duration 15 to 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Mar 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giancarlo Natalucci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giancarlo Natalucci, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065385
- Sponsor's protocol ID
- BASEC 2020-02598
- Acronym
- EveryPrem
- Status last verified
- Apr 2026
- First submitted
- 22 Sep 2021
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EveryPrem Project: Evaluating the INTER-NDA for Standardized Neurodevelopmental Screening at 2 Years of Age for Children Born Preterm.
- ClinicalTrials.gov ID
- NCT05065385
- Acronym / sponsor ID
- EveryPrem / BASEC 2020-02598
- Conditions
- Prematurity
- Keywords
- Prematurity, Neurodevelopement, Follow-up, Screening, INTER-NDA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Giancarlo NatalucciUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neurodevelopmental follow-up of infants at high-risk such as preterm born is necessary in order to early detect impairments and early start a supportive/therapeutic intervention. Valid tools should be available for screening infants with developmental problems even where resources are limited. Such screening would ensure an adequate medical care during and after hospital discharge as well as evidence-based parental pre- and postnatal counselling. While in Switzerland, these tools are specifically needed for the neurodevelopmental surveillance of moderate to late pretem born infants, in low- and mid-income countries, they are needed to monitor the whole population of preterm born infants.
To fill this important gap, the present study aims to determine whether it is feasible to extend neurodevelopmental screening (currently offered to only a very small part of children born preterm), by using a new cost-effective neurodevelopmental assessment, the INTERGROWTH-21st Neurodevelopment Assessment (INTER-NDA, www.inter-nda.com Assessment) at age 2 years.
Detailed description
The pirmary objectives of the study are:
- In very preterm born infants (born < 32 weeks' gestation)
- To assess the concurrent validity of the INTER-NDA with the Bayley-III[13] at 2 years of corrected age in VPT infants.
- In moderate to late preterm infants (born between 32 and 36 weeks' gestation) - To screen neurodevelopment performances at corrected 2 years of corrected age in MLPT infants by means of the INTER-NDA and to compare values with international INTER-NDA standard values.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTER-NDAAlso: Bayley Scales of Infant and Toddler Development, 3rd EditionNeurodevelopmental Screening Test at age 2 years. | Diagnostic test | – |
Primary outcome
INTER-NDA domain scores and centiles
Time frame: At age 18 to 20 months; test duration 15 to 20 minutes.
The INTERGROWTH-21st Neurodevelopment Assessment (INTER-NDA) is new cost-effective neurodevelopmental assessment for 2-year old infants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity, run by Giancarlo Natalucci at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INTER-NDA domain scores and centiles (time frame: At age 18 to 20 months; test duration 15 to 20 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.