Evaluation of an Early Support Programme in Orthophony

Preterm Birth Clinical Trial

— PAPEV-ortho  

Official title:

Evaluation of an Early Support Programme in Orthophony : the PAPEV-ortho Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04384328
• Other study ID #: 2018-A01898-47
• Status: Terminated
• Phase: N/A
• Start date: November 27, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Parents of eligible children are informed of the study either during the hospitalization of the neonatal newborn by a hospital physician, or during a consultation performed during the first 6 months by a pilot physician from the RPSOF-ASNR network, hospital or private practitioner. Parents who agree that the data collected about their child may be used in the study sign a written declaration of free and informed consent.

The Early Support Programme in orthophony (PAPEV-ortho) is systematically proposed to families with possible access to a language therapist in the network.

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. The support focuses on:

• the development of parental sensitivity and receptivity

• the development of parental reactivity

• optimization of communication sequences in routine acts and play

• the development of the child's intentionality in play and routine acts

• support for verbal and non-verbal oral communication The participation of the child and his or her parents in the study ends at the end of the consultations and evaluations carried out at 24 months of corrected age.

Children within the group that followed the PAPEV-ortho program will be compared to children who did not benefit from this program.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 76
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Premature birth < 32 weeks of amenorrhea

• or premature birth with intrauterine growth restriction (IUGR) < P3

• corrected age = 6 months at the time of inclusion

• affiliation to a social security system + mutual insurance

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Language Development Disorders
• Premature Birth
• Preterm Birth

Intervention

Other:
• Early Support Programme in Orthophony
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.

Locations

Country	Name	City	State
France	Ho^pital Antoine Be´cle`re	Clamart
France	Centre Hospitalier Louis Mourier	Colombes
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes
France	Centre Hospitalier Rives de Seine	Neuilly-sur-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

References & Publications (16)

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. E — View Citation

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.16 — View Citation

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. — View Citation

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):1075-8 — View Citation

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. — View Citation

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. — View Citation

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.00 — View Citation

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 — View Citation

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' gestati — View Citation

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. — View Citation

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 — View Citation

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: 1 — View Citation

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;6 — View Citation

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. d — View Citation

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. — View Citation

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 — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Failure rate of implementation of the early support program in speech-language pathology or early drop-out.	Early drop-out is defined by 3 or less sessions.	at 24 months of corrected age
Secondary	Score in the Ages & Stages Questionnaires communication domain at 12 and 18 months of corrected age.	The Ages & Stages Questionnaires is a parental questionnaire that is strongly correlated with traditional developmental tests. The Ages & Stages Questionnaires communication domain takes into account receptive and expressive language, includes 6 questions, and ranges from 0 (worst) to 60 (best).	at 12 and 18 months of corrected age.
Secondary	score at Inventaire Français du Développement Communicatif questionnaire at 12, 18 and 24 months of corrected age	The IFDC questionnaire is a recommended tool for monitoring and early detection of language deficits. It is expressed as a percentile (0=worst, 100=best).	at 12, 18 and 24 months of corrected age
Secondary	Score at Communication and Symbolic Behavior Scales questionnaire at 12 and 24 months of corrected age	The Communication and Symbolic Behavior Scales qestionnaire is a tool for screening for communication disorders and interactions. It ranges from 0 (worst) tro 57 (best).	at 12 and 24 months of corrected age