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

NCT05065385 | Active Not Recruiting

• 1 other identifier: BASEC 2020-02598
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prematurity

Keywords

Prematurity; Neurodevelopement; Follow-up; Screening; INTER-NDA

Outcome Measures

Primary Outcomes (1)

• INTER-NDA domain scores and centiles

  The INTERGROWTH-21st Neurodevelopment Assessment (INTER-NDA) is new cost-effective neurodevelopmental assessment for 2-year old infants.

  At age 18 to 20 months; test duration 15 to 20 minutes.

Interventions

INTER-NDA DIAGNOSTIC_TEST

Neurodevelopmental Screening Test at age 2 years.

Also known as: Bayley Scales of Infant and Toddler Development, 3rd Edition

Eligibility Criteria

• Age: 18 Months - 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Giancarlo Natalucci: lead

Study Sites (1)

Department of Neonatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 4, 2021
• Study Start: March 1, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CH (1)