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

Sponsor

Giancarlo Natalucci (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05065385

Collaborator

(none)

800

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prematurity	Diagnostic Test: INTER-NDA

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

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

INTER-NDA domain scores and centiles [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 30 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Giancarlo Natalucci

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giancarlo Natalucci, Prof. Dr. med., University of Zurich

ClinicalTrials.gov Identifier:

NCT05065385

Other Study ID Numbers:

BASEC 2020-02598

First Posted:

Oct 4, 2021

Last Update Posted:

Oct 4, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Giancarlo Natalucci, Prof. Dr. med., University of Zurich

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Oct 4, 2021