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Very Preterm Children With Language Delay and Parent Intervention

Information source: Lille Catholic University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preterm Birth; Language Development; Speech Therapy

Intervention: Parent-implemented intervention (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: Lille Catholic University

Official(s) and/or principal investigator(s):
Amélie Lansiaux, MD, PhD, Study Chair, Affiliation: Groupment des Hôpitaux de l'Institut Catholique de Lille
Marie-Laure Charkaluk, MD, PhD, Study Director, Affiliation: Hôpital Saint-Vincent-de-Paul, GHICL

Overall contact:
Mélanie Hamez, Med Monitor, Email: hamez.melanie@ghicl.net


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.

Clinical Details

Official title: Parent-implemented Intervention for Very Preterm Children With Language Delay

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: language score of the Developmental Neuropsychological assessment (NEPSY)

Secondary outcome:

Other scores of the NEPSY battery

Strengths and Difficulties Questionnaire

Parenting Stress Index (PSI) questionnaire

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.


Minimum age: 28 Months. Maximum age: 32 Months. Gender(s): Both.


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


- Parents who do not speak French at all

- Triplets

Locations and Contacts

Mélanie Hamez, Med Monitor, Email: hamez.melanie@ghicl.net

Centre Hospitalier, Arras 62000, France; Recruiting
Amélie Kieffer, MD, Principal Investigator

Centre Hospitalier Universitaire, Caen 14000, France; Recruiting
Valérie Datin-Dorrière, MD, Principal Investigator

Centre Hospitalier Universitaire, Lille 59000, France; Recruiting
Véronique Pierrat, MD, Principal Investigator

Hôpital Saint Vincent de Paul (GHICL), Lille 59000, France; Recruiting
Marie-Laure Charkaluk, MD, PhD, Principal Investigator

Hôpital femme mère enfant, Lyon, France; Not yet recruiting
Olivier Claris, MD, Email: olivier.claris@chu-lyon.fr

Centre Hospitalier Universitaire, Marseille, France; Recruiting
Catherine Gire, MD, Principal Investigator

Centre Hospitalier Universitaire, Nantes, France; Not yet recruiting
Julie Boyer, MD, Principal Investigator

AP-HP Hôpital Antoine Béclère, Paris, France; Not yet recruiting
Veronique Zupan, MD

Hôpital Necker, Paris, France; Not yet recruiting
Alexandre Lapillonne, MD

HôpitalCochin - Port Royal, Paris, France; Not yet recruiting
Saoud Kout, MD

Centre Hospitalier, Roubaix 59100, France; Not yet recruiting
Nora Haouari, MD, Principal Investigator

Centre hospitalier Universitaire, Rouen 76000, 76100, France; Not yet recruiting
Aude Charollais, MD, Principal Investigator

Centre Hospitalier Universitaire, Strasbourg 67000, France; Recruiting
Anne De Saint Martin, MD, Principal Investigator

Centre Hospitalier Universitaire, Tours 37044, France; Not yet recruiting
Elie Saliba, MD, Principal Investigator

Centre Hospitalier, Valenciennes 59300, France; Not yet recruiting
Fabien Lapeyre, MD, Principal Investigator

Additional Information

Starting date: January 2014
Last updated: May 29, 2015

Page last updated: August 23, 2015

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