NCT05065385

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Giancarlo Natalucci · Academic / Other
• Sex: All
• Age: 18 Months – 30 Months
• Healthy volunteers: Accepted

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. 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: 1. 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. 2. 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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	INTER-NDA	Neurodevelopmental Screening Test at age 2 years.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-12-31
• Completion: 2026-12-31
• First posted: 2021-10-04
• Last updated: 2026-04-14

Locations

1 site across 1 country: Switzerland