Very Preterm Children With Language Delay and Parent Intervention

Preterm Birth Clinical Trial

— EPILANG  

Official title:

Parent-implemented Intervention for Very Preterm Children With Language Delay

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02042235
• Other study ID #: RC-P0027
• Status: Terminated
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 31, 2018

Study information

• Verified date: March 2020
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Months to 32 Months

Eligibility

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

Related Conditions & MeSH terms

• Communication Disorders
• Language Development
• Language Development Disorders
• Premature Birth
• Preterm Birth
• Speech Therapy

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier	Arras
France	Centre Hospitalier Universitaire	Caen
France	Centre Hospitalier Universitaire	Lille
France	Hôpital Saint Vincent de Paul (GHICL)	Lille
France	Hôpital femme mère enfant	Lyon
France	Centre Hospitalier Universitaire	Marseille
France	Centre Hospitalier Universitaire	Nantes
France	AP-HP Hôpital Antoine Béclère	Paris
France	Hôpital Necker	Paris
France	HôpitalCochin - Port Royal	Paris
France	Centre Hospitalier	Roubaix
France	Centre hospitalier Universitaire	Rouen
France	Centre Hospitalier Universitaire	Strasbourg
France	Centre Hospitalier Universitaire	Tours
France	Centre Hospitalier	Valenciennes

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	language score of the Developmental Neuropsychological assessment (NEPSY)	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	at 36 months of corrected age
Secondary	Other scores of the NEPSY battery	To evaluate the child's neuropsychological functioning	at 36 months of corrected age
Secondary	Strengths and Difficulties Questionnaire		at 36 months of corrected age
Secondary	Parenting Stress Index (PSI) questionnaire		at 36 months of corrected age