Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-29 @ 9:19 PM
Study NCT ID:
NCT02042235
Status:
TERMINATED
Last Update Posted:
2020-03-03
First Post:
2014-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Very Preterm Children With Language Delay and Parent Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D007802', 'term': 'Language'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'whyStopped': 'difficulted recruiting', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2014-01-20', 'studyFirstSubmitQcDate': '2014-01-21', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'language score of the Developmental Neuropsychological assessment (NEPSY)', 'timeFrame': 'at 36 months of corrected age', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Other scores of the NEPSY battery', 'timeFrame': 'at 36 months of corrected age', 'description': "To evaluate the child's neuropsychological functioning"}, {'measure': 'Strengths and Difficulties Questionnaire', 'timeFrame': 'at 36 months of corrected age'}, {'measure': 'Parenting Stress Index (PSI) questionnaire', 'timeFrame': 'at 36 months of corrected age'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prematurity', 'language', 'parent-implemented intervention', 'speech therapy', 'neurodevelopment'], 'conditions': ['Preterm Birth', 'Language Development', 'Speech Therapy']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.", 'detailedDescription': '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.\n\nSome 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.\n\nDuring 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.\n\nThe 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.\n\nThe usual "wait-and-see" attitude will be provided to the control group, together with basic advice to enhance the child\'s language at home.\n\nIn 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.\n\nAt 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.\n\nThe analysis will be according to intention to treat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Months', 'minimumAge': '28 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child born at 24 to 31+6 weeks' gestation, whose parents did not refuse collection of follow-up data\n* Child aged 30 ± 2 months corrected age (CA) at inclusion\n* 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.\n* Child with a global Developmental Quotient (DQ) ≥ 55 at 30 months CA\n* Child whose parents accept participation in this study\n* Child with French health insurance coverage\n\nExclusion Criteria:\n\n* 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.\n* Blindness\n* Deafness defined by the prescription of a hearing aid\n* Child with a chromosomal or other condition that could interfere with language development\n* Parents who do not speak French at all\n* Triplets"}, 'identificationModule': {'nctId': 'NCT02042235', 'acronym': 'EPILANG', 'briefTitle': 'Very Preterm Children With Language Delay and Parent Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Lille Catholic University'}, 'officialTitle': 'Parent-implemented Intervention for Very Preterm Children With Language Delay', 'orgStudyIdInfo': {'id': 'RC-P0027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parent-implemented language intervention', 'description': '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.', 'interventionNames': ['Behavioral: Parent-implemented intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "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 …)."}], 'interventions': [{'name': 'Parent-implemented intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Parent-implemented language intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62000', 'city': 'Arras', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Saint Vincent de Paul (GHICL)', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital femme mère enfant', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Hôpital Antoine Béclère', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'HôpitalCochin - Port Royal', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '59100', 'city': 'Roubaix', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'zip': '76000, 76100', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre hospitalier Universitaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '59300', 'city': 'Valenciennes', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}], 'overallOfficials': [{'name': 'Amélie Lansiaux, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Groupment des Hôpitaux de l'Institut Catholique de Lille"}, {'name': 'Marie-Laure Charkaluk, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital Saint-Vincent-de-Paul, GHICL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lille Catholic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}