NCT01426659

Brief Summary

The preterm children have more difficulty minor neurological developmental than the general population even without cerebral palsy. Their oral language difficulties of language and writing have been little studied. The investigators propose to study spoken language has 3 years 1/2 and stimulate or not (depending on randomization) children with phonological weaknesses notemment language. The investigators will evaluate stimulation protocol implied short and precise language in a re-education "say and do" in 20 sessions. A new evaluation of language (BILO and N-EEL), sensorimotor and cognitive constraints (KABC) will be performed at 4 years. Early intervention on the basis of precise language before closing the window developmental (\<5 years) is expected to improve as a result of language and cognitive development of preterm infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

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

August 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

3.4 years

First QC Date

August 29, 2011

Last Update Submit

June 2, 2015

Conditions

Disorder of Speech and Language Development

Keywords

languageconstraintsprematurephonologyimpliedearly development (< 5 years)

Outcome Measures

Primary Outcomes (1)

  • parental endorsement of stimulation

    stimulation every day image of the Protocol

    for at least 15 weeks

Secondary Outcomes (1)

  • come following a speech therapy every week

    15 weeks

Study Arms (2)

Protocol "say and do"

ACTIVE COMPARATOR

reeducation implicit 5 minutes every day at home and 30 minutes of speech therapy every week

Behavioral: parental stimulation according to protocol

no stimulation "say and do"

ACTIVE COMPARATOR
Behavioral: parental stimulation according to protocol

Interventions

parental stimulation according to protocolBEHAVIORAL

verbal stimulation every day image of the Protocol "Dire et Faire"

Protocol "say and do"no stimulation "say and do"

Eligibility Criteria

Age34 Months - 38 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Premature \< 32 without CP,
  • criteria of fragility BILO

You may not qualify if:

  • blindness,
  • deafness,
  • abnormal karyotype results in normal or pathological BILO

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Hospital

Rouen, Haute Normandie, 76000, France

Location

University Hospital

Caen, 14033, France

Location

University Hospital

Grenoble, 38 043, France

Location

University Hospital

Le Havre, 76600, France

Location

Centre Jacques Cartier

Saint-Brieuc, 22070, France

Location

University Hospital

Tours, 37000, France

Location

Related Publications (2)

  • Charollais A, Stumpf MH, Beaugrand D, Lemarchand M, Radi S, Pasquet F, Khomsi A, Marret S. [Evaluation of language at 6 years in children born prematurely without cerebral palsy: prospective study of 55 children]. Arch Pediatr. 2010 Oct;17(10):1433-9. doi: 10.1016/j.arcped.2010.06.012. Epub 2010 Aug 16. French.

    PMID: 20719486BACKGROUND

  • Charollais A, Laudenbach V, Stumpf MH, Delaporte B, Datin-Dorriere V, Debillon T, De Barace C, Flechelles O, Farmer M. Impact of an early educational protocol on the oral language of children born preterm exhibiting phonological fragility: a multicenter randomized clinical trial. Front Psychol. 2024 Dec 5;15:1393246. doi: 10.3389/fpsyg.2024.1393246. eCollection 2024.

    PMID: 39703879DERIVED

MeSH Terms

Conditions

LanguagePremature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

  • A Charollais

    UH Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2011

First Posted

August 31, 2011

Study Start

September 1, 2011

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

FR(6)