NCT03700619

Brief Summary

Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidence of executive functions is not described for preterm infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
355

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 30, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

October 5, 2018

Last Update Submit

September 8, 2021

Conditions

Preterm Infant

Outcome Measures

Primary Outcomes (1)

  • Incidence of disorders of executive functions in 11 to 12 year old in former preterm of gestational age less than 34 weeks, from the Behavioral Rating Inventory of Executive Function questionnaire.

    The sum of the 86 items is calculated.

    11 to 12 years after preterm birth.

Secondary Outcomes (1)

  • Find neonatal factors associated with executive functions disorders in former prematures in 11 to 12 year old

    11 to 12 years after preterm birth

Interventions

BRIEF parental surveyOTHER

estimate incidence of executive functions disorders in preterm children in 11 to 12 year old, born less than 34 weeks of gestation, with the BRIEF parental questionnaire. Effects are potentially important because this study could objectify an increase of risk of executive functions disorders f in preterm children in 11 to 12 year old, and identify associated risk factors. This work could eventually alert pediatrician to be careful at the executive functions and to propose adapted supportive cares.

Eligibility Criteria

Age11 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

patients which former preterm of gestational age less than 34 weeks

You may qualify if:

  • patient in 11 to 12 year old, included in LIFT cohort

You may not qualify if:

  • Congenital abnormalities including nervous system malformations; genetic diseases; incomplete understanding of written and oral French by parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nantes

Nantes, 44000, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 9, 2018

Study Start

January 30, 2019

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

September 10, 2021

Record last verified: 2021-09

Locations

FR(1)