NCT05843266

Brief Summary

The aims of this project are:

  1. 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. 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. 3.To study individual trajectories of attention pattern and development during age.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

March 17, 2023

Last Update Submit

May 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age42 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Low risk preterm children

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityPremature Birth

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Daniela Ricci, Medical Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Pediatric Neurologist

Study Record Dates

First Submitted

March 17, 2023

First Posted

May 6, 2023

Study Start

February 1, 2022

Primary Completion

June 25, 2023

Study Completion

June 30, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations