Early Post Hospital Discharge Psychomotor Therapy Intervention Program: Effect on the Development in Very Preterm Infants at 2-years Corrected Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 20
- 主要终点
- Psychomotor development assessment.
研究概览
简要总结
Our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive disorders and unbalanced between brain and brainstem maturation of the neonatal period involve an early deviant development for immature infants that will be cascaded through the brain scaffolding and later development. The primary purpose is to determine whether the Early Psychomotor Therapy Intervention Program improves development and behavior in very preterm infants (VPI) at 24-month corrected age (CA).
详细描述
VPI < 30 week of amenorrhea were randomized, in a simple blind controlled trial. The psychomotor development was evaluated according to the Bayley Scales of Infant Development-III (BSID-III) at 2 years CA. An intermediate point was provided at 9 months CA. Pediatric standardized assessments and psychologist semi-directive interviews were conducted. Parents also completed a self-administering questionnaire relating to the post-traumatic stress. The intervention consisted on 20 therapy sessions between 2 and 9 months CA, in order to support infants' development, and parent-infant interactions and adjustment.
Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 24 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with a gestational age between 24 and 30 weeks.
排除标准
- •Infants with congenital disease,
- •Infants with brain bleeding grade III-IV,
- •Infants with periventricular leucomalacia,
- •Infants whose mothers had a documented history of physical or mental illness, or drug abuse
- •Infants from non-French -speaking families.
研究组 & 干预措施
Psychomotor therapy
Early post hospital discharge psychomotor therapy.
干预措施: Early post hospital discharge psychomotor therapy (Other)
Control
No specific support.
结局指标
主要结局
Psychomotor development assessment.
时间窗: Year 2
Assessed by the Bayley Scale Third Edition BSID-III.
次要结局
- The acceptability of the protocol by the parents for the intervention group.(Month 9)
- The clinical evolution of the child assessed by a standardized neurological examination.(Months 3, 6, 9, 12, 18, 24)
- The quality of parenting.(Month 9; Year 2)