Evaluation of an Early Support Programme in Orthophony : the PAPEV-ortho Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 76
- 试验地点
- 8
- 主要终点
- Score in the Ages & Stages Questionnaires communication domain at 24 months of corrected age.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard Care
Standard follow-up within the RPSOF-ASNR network, without systematic speech therapy sessions.
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.
干预措施: Early Support Programme in Orthophony (Other)
结局指标
主要结局
Score in the Ages & Stages Questionnaires communication domain at 24 months of corrected age.
时间窗: 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
次要结局
- Score in the Ages & Stages Questionnaires communication domain at 12 and 18 months of corrected age.(at 12 and 18 months of corrected age.)
- Failure rate of implementation of the early support program in speech-language pathology or early drop-out.(at 24 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)