Early Childhood Attention Battery in Preterm Children | NCT05843266

Studies
Early Childhood Attention Battery in Preterm Children

NCT05843266

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Unknown status

Last Update Posted

May 6, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Attention-deficit
Prematurity

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

Jun 25, 2023Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Mar 17, 2023

First Submission Date that Met QC Criteria

May 2, 2023

First Posted Date

May 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2023

Last Update Posted Date

May 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ricci Daniela, Principal Investigator Pediatric Neurologist, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aims of this project are:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

42 Months

Maximum Age

59 Months

Standard Ages

Child

Study Population

Low risk preterm children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniela Ricci, Medical Doctor	Contact	3929477842		d.ricci@iapb.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Gemelli	Recruiting	Rome		00168	Italy

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity
D047928	Premature Birth

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D007752	Obstetric Labor, Premature

Browse Leaves

Not provided

Browse Branches

Not provided