Evaluation of an Early Support Programme in Orthophony

NCT04384328 | Terminated DMC

• 1 other identifier: 2018-A01898-47
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 4

Brief Summary

Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study, to measure the impact of an early support programme in speech and language therapy for vulnerable children (PAPEV-ortho), in children born very prematurely or very hypotrophically, on the incidence of language and communication deficits at the corrected age of 2 years.

Conditions

Language Development Disorders; Preterm Birth

Keywords

language Development; communication Development; preterm infant; orthophony

Outcome Measures

Primary Outcomes (1)

• Score in the Ages & Stages Questionnaires communication domain at 24 months of corrected age.

  Percentage of children with a score of ≤ 45 in the communication domain of the Ages \& Stages Questionnaires questionnaire (from 0=worst to 60=best) at 24 months of corrected age

  at 24 months of corrected age

Secondary Outcomes (4)

• Failure rate of implementation of the early support program in speech-language pathology or early drop-out.

  at 24 months of corrected age

• Score in the Ages & Stages Questionnaires communication domain at 12 and 18 months of corrected age.

  at 12 and 18 months of corrected age.

• score at Inventaire Français du Développement Communicatif questionnaire at 12, 18 and 24 months of corrected age

  at 12, 18 and 24 months of corrected age

• Score at Communication and Symbolic Behavior Scales questionnaire at 12 and 24 months of corrected age

  at 12 and 24 months of corrected age

Study Arms (2)

Early Support Programme in Orthophony

EXPERIMENTAL

Early support in speech therapy lasts between 6 months and 24 months of corrected age. It includes 10 to 20 sessions depending on the child's needs. These sessions are conducted by a speech-language pathologist from the RPSOF-ASNR network, trained in the issues specific to the very premature child and the network's tools.

Other: Early Support Programme in Orthophony

Standard Care

NO INTERVENTION

Standard follow-up within the RPSOF-ASNR network, without systematic speech therapy sessions.

Interventions

Early Support Programme in Orthophony OTHER

Early support in speech therapy lasts between 6 months and 24 months of corrected age. It includes 10 to 20 sessions depending on the child's needs. These sessions are conducted by a speech-language pathologist from the RPSOF-ASNR network, trained in the issues specific to the very premature child and the network's tools.

Early Support Programme in Orthophony

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature birth \< 32 weeks of amenorrhea
• or premature birth with intrauterine growth restriction (IUGR) \< P3
• affiliation to a social security system + mutual insurance

You may not qualify if:

• genetic pathology
• ongoing developmental care: psychomotricity or speech therapy
• neuromuscular pathology affecting oral and facial motor skills
• severe oral disorders: feeding by gastric tube or gastrostomy
• severe sensory, auditory or visual impairment
• neither of the 2 French-speaking parents

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (4)

Hôpital Antoine Béclère

Clamart, 92141, France

Location

Centre Hospitalier Louis Mourier

Colombes, 92700, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

Location

Centre Hospitalier Rives de Seine

Neuilly-sur-Seine, 92200, France

Location

Related Publications (16)

• Pierrat V, Marchand-Martin L, Arnaud C, Kaminski M, Resche-Rigon M, Lebeaux C, Bodeau-Livinec F, Morgan AS, Goffinet F, Marret S, Ancel PY; EPIPAGE-2 writing group. Neurodevelopmental outcome at 2 years for preterm children born at 22 to 34 weeks' gestation in France in 2011: EPIPAGE-2 cohort study. BMJ. 2017 Aug 16;358:j3448. doi: 10.1136/bmj.j3448.

  PMID: 28814566 RESULT

• Nishimura T, Takei N, Tsuchiya KJ, Asano R, Mori N. Identification of neurodevelopmental trajectories in infancy and of risk factors affecting deviant development: a longitudinal birth cohort study. Int J Epidemiol. 2016 Apr;45(2):543-53. doi: 10.1093/ije/dyv363. Epub 2016 Feb 13.

  PMID: 26874928 RESULT

• Sansavini A, Guarini A, Savini S, Broccoli S, Justice L, Alessandroni R, Faldella G. Longitudinal trajectories of gestural and linguistic abilities in very preterm infants in the second year of life. Neuropsychologia. 2011 Nov;49(13):3677-88. doi: 10.1016/j.neuropsychologia.2011.09.023. Epub 2011 Sep 21.

  PMID: 21958647 RESULT

• van Noort-van der Spek IL, Franken MC, Weisglas-Kuperus N. Language functions in preterm-born children: a systematic review and meta-analysis. Pediatrics. 2012 Apr;129(4):745-54. doi: 10.1542/peds.2011-1728. Epub 2012 Mar 19.

  PMID: 22430458 RESULT

• Marchman VA, Fernald A. Speed of word recognition and vocabulary knowledge in infancy predict cognitive and language outcomes in later childhood. Dev Sci. 2008 May;11(3):F9-16. doi: 10.1111/j.1467-7687.2008.00671.x.

  PMID: 18466367 RESULT

• Stolt S, Lind A, Matomaki J, Haataja L, Lapinleimu H, Lehtonen L. Do the early development of gestures and receptive and expressive language predict language skills at 5;0 in prematurely born very-low-birth-weight children? J Commun Disord. 2016 May-Jun;61:16-28. doi: 10.1016/j.jcomdis.2016.03.002. Epub 2016 Mar 9.

  PMID: 26999726 RESULT

• Marchman VA, Loi EC, Adams KA, Ashland M, Fernald A, Feldman HM. Speed of Language Comprehension at 18 Months Old Predicts School-Relevant Outcomes at 54 Months Old in Children Born Preterm. J Dev Behav Pediatr. 2018 Apr;39(3):246-253. doi: 10.1097/DBP.0000000000000541.

  PMID: 29309294 RESULT

• Boyer J, Flamant C, Boussicault G, Berlie I, Gascoin G, Branger B, N'Guyen The Tich S, Roze JC. Characterizing early detection of language difficulties in children born preterm. Early Hum Dev. 2014 Jun;90(6):281-6. doi: 10.1016/j.earlhumdev.2014.03.005. Epub 2014 Apr 13.

  PMID: 24726534 RESULT

• Sanchez K, Spittle AJ, Slattery JM, Morgan AT. Oromotor Feeding in Children Born Before 30 Weeks' Gestation and Term-Born Peers at 12 Months' Corrected Age. J Pediatr. 2016 Nov;178:113-118.e1. doi: 10.1016/j.jpeds.2016.07.044. Epub 2016 Sep 5.

  PMID: 27609073 RESULT

• Telford EJ, Fletcher-Watson S, Gillespie-Smith K, Pataky R, Sparrow S, Murray IC, O'Hare A, Boardman JP. Preterm birth is associated with atypical social orienting in infancy detected using eye tracking. J Child Psychol Psychiatry. 2016 Jul;57(7):861-8. doi: 10.1111/jcpp.12546. Epub 2016 Mar 2.

  PMID: 26934180 RESULT

• Eeles AL, Anderson PJ, Brown NC, Lee KJ, Boyd RN, Spittle AJ, Doyle LW. Sensory profiles obtained from parental reports correlate with independent assessments of development in very preterm children at 2 years of age. Early Hum Dev. 2013 Dec;89(12):1075-80. doi: 10.1016/j.earlhumdev.2013.07.027. Epub 2013 Aug 24.

  PMID: 23978398 RESULT

• Zuccarini M, Guarini A, Savini S, Iverson JM, Aureli T, Alessandroni R, Faldella G, Sansavini A. Object exploration in extremely preterm infants between 6 and 9 months and relation to cognitive and language development at 24 months. Res Dev Disabil. 2017 Sep;68:140-152. doi: 10.1016/j.ridd.2017.06.002. Epub 2017 Aug 3.

  PMID: 28779627 RESULT

• Charkaluk ML, Truffert P, Fily A, Ancel PY, Pierrat V; Epipage study group. Neurodevelopment of children born very preterm and free of severe disabilities: the Nord-Pas de Calais Epipage cohort study. Acta Paediatr. 2010 May;99(5):684-9. doi: 10.1111/j.1651-2227.2010.01695.x.

  PMID: 20491713 RESULT

• Crunelle D, Le Normand MT, Delfosse MJ. [Oral and written language production in prematures children: results in 7 1/2-year-old]. Folia Phoniatr Logop. 2003 May-Jun;55(3):115-27. doi: 10.1159/000070723. French.

  PMID: 12771463 RESULT

• Forcada-Guex M, Pierrehumbert B, Borghini A, Moessinger A, Muller-Nix C. Early dyadic patterns of mother-infant interactions and outcomes of prematurity at 18 months. Pediatrics. 2006 Jul;118(1):e107-14. doi: 10.1542/peds.2005-1145.

  PMID: 16818525 RESULT

• Spittle A, Orton J, Anderson PJ, Boyd R, Doyle LW. Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants. Cochrane Database Syst Rev. 2015 Nov 24;2015(11):CD005495. doi: 10.1002/14651858.CD005495.pub4.

  PMID: 26597166 RESULT

MeSH Terms

Conditions

Language Development Disorders; Premature Birth

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Michèle Granier, MD

  Centre Hospitalier Sud Francilien

  STUDY DIRECTOR

• Véronique Zupan-Simunek, MD

  Hôpital Antoine Béclère

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study.

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: May 12, 2020
• Study Start: November 27, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 17, 2023

Record last verified: 2022-11

Locations

FR (4)