Early Childhood Attention Battery in Preterm Children

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843266
• Other study ID #: 4685
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Daniela Ricci, Medical Doctor
• Phone: 3929477842
• Email: d.ricci[@]iapb.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 Months to 59 Months

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Premature Birth
• Prematurity

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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