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Very Preterm Children With Language Delay and Parent Intervention (EPILANG)

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ClinicalTrials.gov Identifier: NCT02042235
Recruitment Status : Recruiting
First Posted : January 22, 2014
Last Update Posted : May 3, 2016
Ministry of Health, France
Information provided by (Responsible Party):
Lille Catholic University

Brief Summary:

In studies of children born at term, language delay at the age of 2 years exhibits a spontaneously favourable course in 30 to 50% by the age of 3 years. In France, there is no recommendation for speech therapy before the age of 3 years. However, for term-born children, parent-implemented language interventions conducted during the third year of life have already shown a positive short-term effect on language skills. In these interventions, a skilled interventionist, generally a speech therapist, teaches parents how to use specific language strategies with their child.

The investigators' hypothesis is that such parent-implemented interventions would be particularly appropriate at short and medium term for the improvement of linguistic performances in very preterm children, a population with a high prevalence of early language delay. Currently, there is an opportunity to partly nest an intervention trial in a national prospective population-based cohort of very preterm children, the EPIPAGE (Etude EPIdémiologique sur les Petits Ages GEstationnels) 2 cohort, which has included 5 000 babies born alive in France in 2011. This situation provides considerable methodological advantages.

Condition or disease Intervention/treatment
Preterm Birth Language Development Speech Therapy Behavioral: Parent-implemented intervention

Detailed Description:

EPILANG is an open randomized controlled study, in which the final assessment of the children (endpoint) will be conducted by professionals blinded to the treatment group.

Some eligible children will first be screened using the parental questionnaire at 24 months corrected age (CA) of the EPIPAGE 2 cohort. Children with language delay, defined as no words combination and/or less than 30 words from Mac Arthur CDI - short version, and free of exclusion criteria, will be invited to an inclusion visit at 30 months CA, if they are in an EPIPAGE 2 centre participating in the EPILANG trial.

During the inclusion visit, inclusion criteria and the absence of exclusion criteria will be checked, data useful for the study will be collected, and the informed consent of the parents collected. The child will then be randomized either in the control or the intervention group if language delay is still present, defined by a score < 10th percentile at the Mac Arthur CDI. Twins, if both included, will be included in the same group, otherwise only the twin with a language delay will be randomized.

The intervention is organized in 15 weekly one-hour sessions with the child, one or both parents and a speech therapist recruited and trained for the study. Maximum duration for the intervention will be 6 months per child, because some sessions can be missed or delayed. Parents' participation will be recorded.

The usual "wait-and-see" attitude will be provided to the control group, together with basic advice to enhance the child's language at home.

In both groups, audition will be checked by an otolaryngology specialist, following professional recommendations, and care will be provided in case of hearing deficit, if appropriate.

At 3 years CA, a neuropsychological evaluation will be performed by trained psychologists for both groups, blinded for the allocation group. Behaviour will be evaluated with a validated parental questionnaire.

The analysis will be according to intention to treat.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Parent-implemented Intervention for Very Preterm Children With Language Delay
Study Start Date : January 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: Parent-implemented language intervention
In the intervention group, the techniques and attitudes favouring use of oral language will be taught to the parents during 15 sessions with the parent(s) and child.
Behavioral: Parent-implemented intervention
In order to achieve the programme of parent-implemented language intervention, a detailed protocol for speech therapists recruited and trained for the present study has been established. The techniques and attitudes favouring use of oral language will be taught to the parents during 15 sessions with the parent(s) and child.
No Intervention: Control group
The control group will benefit from the actual routine care for children with language delay before the age of 3 years. In order to provide them the best routine care, the psychologist will provide some advice to the parents to enhance their child's language (e.g.: using life situations to talk with the child and encourage him/her to talk …).

Primary Outcome Measures :
  1. language score of the Developmental Neuropsychological assessment (NEPSY) [ Time Frame: at 36 months of corrected age ]
    For the main outcome, mean language score on the NEPSY at the final visit, our primary endpoint, will be compared between groups using linear regression

Secondary Outcome Measures :
  1. Other scores of the NEPSY battery [ Time Frame: at 36 months of corrected age ]
    To evaluate the child's neuropsychological functioning

  2. Strengths and Difficulties Questionnaire [ Time Frame: at 36 months of corrected age ]
  3. Parenting Stress Index (PSI) questionnaire [ Time Frame: at 36 months of corrected age ]

Information from the National Library of Medicine

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Ages Eligible for Study:   28 Months to 32 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Child born at 24 to 31+6 weeks' gestation, whose parents did not refuse collection of follow-up data
  • Child aged 30 ± 2 months corrected age (CA) at inclusion
  • Child with language delay at 24 months CA, defined as the absence of word combination and/or expressive vocabulary of less than 30 words according to the short version of the French Mac Arthur Communication Developmental Inventories (CDI), whose language delay is confirmed at 30 months CA i.e. without word combination and/or an expressive vocabulary below the 10th percentile on the French CDI.
  • Child with a global Developmental Quotient (DQ) ≥ 55 at 30 months CA
  • Child whose parents accept participation in this study
  • Child with French health insurance coverage

Exclusion Criteria:

  • Child with neurological sequelae (delay or disability) and who is unable to walk without assistance at 24 months CA or who has a global DQ < 55 on the revised Brunet-Lézine (BLR) scale at 30 months CA.
  • Blindness
  • Deafness defined by the prescription of a hearing aid
  • Child with a chromosomal or other condition that could interfere with language development
  • Parents who do not speak French at all
  • Triplets

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042235

Contact: Mélanie Hamez, Med Monitor hamez.melanie@ghicl.net
Contact: Gabriela Certad, MD, PhD +33 3 20 22 57 35 certad.gabriela@ghicl.net

Centre Hospitalier Recruiting
Arras, France, 62000
Principal Investigator: Amélie Kieffer, MD         
Centre Hospitalier Universitaire Recruiting
Caen, France, 14000
Principal Investigator: Valérie Datin-Dorrière, MD         
Centre Hospitalier Universitaire Recruiting
Lille, France, 59000
Principal Investigator: Véronique Pierrat, MD         
Hôpital Saint Vincent de Paul (GHICL) Recruiting
Lille, France, 59000
Principal Investigator: Marie-Laure Charkaluk, MD, PhD         
Hôpital femme mère enfant Not yet recruiting
Lyon, France
Contact: Olivier Claris, MD       olivier.claris@chu-lyon.fr   
Centre Hospitalier Universitaire Recruiting
Marseille, France
Principal Investigator: Catherine Gire, MD         
Centre Hospitalier Universitaire Not yet recruiting
Nantes, France
Principal Investigator: Julie Boyer, MD         
AP-HP Hôpital Antoine Béclère Not yet recruiting
Paris, France
Contact: Veronique Zupan, MD         
Hôpital Necker Not yet recruiting
Paris, France
Contact: Alexandre Lapillonne, MD         
HôpitalCochin - Port Royal Not yet recruiting
Paris, France
Contact: Saoud Kout, MD         
Centre Hospitalier Not yet recruiting
Roubaix, France, 59100
Principal Investigator: Nora Haouari, MD         
Centre hospitalier Universitaire Not yet recruiting
Rouen, France, 76000, 76100
Principal Investigator: Aude Charollais, MD         
Centre Hospitalier Universitaire Recruiting
Strasbourg, France, 67000
Principal Investigator: Anne De Saint Martin, MD         
Centre Hospitalier Universitaire Not yet recruiting
Tours, France, 37044
Principal Investigator: Elie Saliba, MD         
Centre Hospitalier Not yet recruiting
Valenciennes, France, 59300
Principal Investigator: Fabien Lapeyre, MD         
Sponsors and Collaborators
Lille Catholic University
Ministry of Health, France
Study Chair: Amélie Lansiaux, MD, PhD Groupment des Hôpitaux de l'Institut Catholique de Lille
Study Director: Marie-Laure Charkaluk, MD, PhD Hôpital Saint-Vincent-de-Paul, GHICL

Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02042235     History of Changes
Other Study ID Numbers: RC-P0027
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016

Keywords provided by Lille Catholic University:
parent-implemented intervention
speech therapy

Additional relevant MeSH terms:
Communication Disorders
Premature Birth
Language Development Disorders
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Language Disorders