The EveryPrem Project: Evaluating the INTER-NDA for Standardized Neurodevelopmental Screening at 2 Years of Age for Children Born Preterm.

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.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 month–30 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neonatology

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INTER-NDA

Diagnostic Test

Neurodevelopmental Screening Test at age 2 years.

Other names: Bayley Scales of Infant and Toddler Development, 3rd Edition

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Giancarlo Natalucci

Other

Registry information

Acronym: EveryPrem

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2026
First posted: Oct 4, 2021
Registry last updated: Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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