NCT03700463

Brief Summary

Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidenceof 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
356

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

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
7 days until next milestone

Study Start

First participant enrolled

October 16, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

October 5, 2018

Last Update Submit

August 21, 2019

Conditions

Preterm Infant

Outcome Measures

Primary Outcomes (1)

  • Incidence of disorders of executive functions in 3 to 4 year old which former preterm of gestational age less than 34 weeks, from the Behavioral Rating Inventory of Executive Function questionnaire.

    sum of 63 items is calculated

    3 to 4 years after preterm birth

Secondary Outcomes (1)

  • neonatal factors

    3 to 4 years after preterm birth

Interventions

BRIEF parental surveyOTHER

Estimate incidence of executive functions disorders in preterm children in 3 to 4 year old, born less than 34 weeks of gestation

Eligibility Criteria

Age3 Years - 4 Years
Sexall
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 3 to 4 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

Related Publications (1)

  • Reynold de Seresin M, Roy A, Theveniaut C, Le Goff J, Chopin C, Rouger V, Roze JC, Flamant C, Muller JB. Assessing of executive functions in daily life in preterm children aged 3-4 years old from the "Behavior Rating Inventory of Executive Function-Preschool version" questionnaire. Front Pediatr. 2023 Jul 26;11:999100. doi: 10.3389/fped.2023.999100. eCollection 2023.

    PMID: 37565238DERIVED

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
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 9, 2018

Study Start

October 16, 2018

Primary Completion

June 15, 2019

Study Completion

June 15, 2019

Last Updated

August 26, 2019

Record last verified: 2019-08

Locations

FR(1)