Early Childhood Attention Battery in Preterm Children

A Study on the Application of the Early Childhood Attention Battery in a Population of Preterms Children

The aims of this project are:

1. To explore, using the ECAB, if and in which measure the attentional abilities of young preterm children are different from term peers, whom reference data are already published27.
2. To correlate the ECAB results with the "Conner's Teacher, Rating Scale- Revised e Conner's Parent Rating Scale", one of the available diagnostic interview that helps to identify signs of Attention Deficit Hyperactivity Disorder (ADHD) in young children, at the age of 6 years and over.
3. To study individual trajectories of attention pattern and development during age.

Study Overview

• Status: Recruiting
• Conditions: Prematurity; Attention-deficit

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Daniela Ricci, Medical Doctor; Phone Number: 3929477842; Email: d.ricci@iapb.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Gemelli
    • Contact: Daniela Ricci; Phone Number: +393929477842; Email: d.ricci@iapb.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Low risk preterm children

Description

Inclusion Criteria:

• gestational age (GA) <34 weeks, intellectual functioning with Intelligence Quotient (IQ>70 verified with Wechsler scales performed within 6 months from the ECAB, age at ECAB assessment between 3 years and 5 years 11 months.

Exclusion Criteria:

• presence of major brain lesions, major motor or behavioral disorders, WPPSI-III subtest receptive vocabulary with a scaled score <8.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
attentional abilities of young preterm children	The Early Childhood Attention Battery (ECAB) consists of 8 subtest assessing 3 aspects of attention: selective attention, sustained attention, attentional control. Counting the number of correct answer we get a raw scores (with a different range for each task) that can be translated in a pondered score and in a percentile based on normative data collected on term born children and previously published	3 years

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): June 25, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Premature Birth; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 4685

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No