Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 15
- 主要终点
- To assess the effect of the Infant Behavior Assessment and Intervention Program Program (IBAIP) in very preterm infants (< 33 weeks of gestation) on neurodevelopment at the corrected age of 2 years
研究概览
简要总结
Mortality in very preterm infants has decreased significantly over the past twenty years. However, neuromotor, behavioral and cognitive development disorders are more common in these children born before 33 weeks of gestation as compared to term born infants.
These neurodevelopmental disorders include difficulties with self-regulation, tone, posture or poor quality movements as well as inadequate responses to sensory simulation.
Post-hospital discharge follow-up and interventionsof children born very preterm ares very heterogeneous in France. They are mainly carried out in a rehabilitation center, based on caregivers whereas IBAIP is carried out at home and family centered.
Early interventions during hospitalization or after discharge appear potentially of great interest in improving the neurodevelopemental outcome of the very preterm infants. Several early interventions have been developed and evaluated in other countries. These interventions are designed to be used early in life, mainly during the first 3 years of life, and are based on brain plasticity and intense synaptogenesis during this period of life.
The IBAIP (Infant Behavior Assessment and Intervention Program) was developed on the same theoretical foundations as the NIDCAP (Neonatal Individualized Development Care and Assessment Program). IBAIP consists of providing the child and his family with an intervention, at home, starting just before hospital discharge up to a 6 months corrected age. .The aim of IBAIP is to support developmental functions including infant's self-regulation and focus on improving the responsiveness of parents' infant interactions.
详细描述
This program consists of providing intervention, by a IBAIP trained and certified healthcare professional, with the child and his family, starting a few days before hospitalization discharge (hospital or home care) and continuing at home until the corrected age of 6 months. It focuses on the child's behaviors and consists of assisting the family in its interactions with the child so that these are adapted and responsive to the child's development needs over time through repeated interventions.
A cluster randomization will be used meaning the centers are randomized, not the individual patients. The centers will be randomized before the inclusion of patients in order to allow the physiotherapists or psychomotor therapists to be trained and certified to the IBAIP before the start of the trial.
Visit 1: Upon discharge from hospital, follow-up as part of standard care (control group) with at least 1 medical consultation per month during the first 6 months or according to the IBAIP program (experimental group) with one intervention before discharge from hospital and at home after hospital discharge, with1 session once a month up to 6 months corrected age (i.e. 6 to 8 sessions) in addition to standard care.
Visit 2: At 6 months corrected age, parents' response to the PSI (Parenting Stress Index) questionnaire.
Visit 3: At two years corrected age :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born (including multiple pregnancies) at a gestational age between 25 weeks +0 days and 32 weeks + 6days.
- •Written informed consent of at least one of the parents / legal guardian or 2 parents / legal guardians depending on the family context
- •Normal neurological examination between 36 and 41 weeks of corrected age
排除标准
- •Intraventricular hemorrhage (III or IV), periventricular leukomalacia
- •Brain MRI abnormalities performed after 36 weeks of corrected age
- •Life-threatening pathology
- •Severe congenital abnomality
- •Severe maternal pathology (physical and / or mental)
- •Parents whose native language is not French
- •Participation in another interventional study on the management of post-hospital neurodevelopment disorders
研究组 & 干预措施
IBAIP Group
Children benefiting from assessment and intervention providing by a healthcare professional (physiotherapist or psychomotor therapist) trained and certified for IBAIP. This care will take place upon discharge from the hospital at the rate of one session per month for 6 months. The sessions will take place in the presence of at least one of the parents and at home. These children will also benefit from standard follow-up (medical follow-up, paramedical or specialized medical support depending on the development and needs).
干预措施: IBAIP : Infant Behaviour Assessment and Intervention Program (Other)
IBAIP Group
Children benefiting from assessment and intervention providing by a healthcare professional (physiotherapist or psychomotor therapist) trained and certified for IBAIP. This care will take place upon discharge from the hospital at the rate of one session per month for 6 months. The sessions will take place in the presence of at least one of the parents and at home. These children will also benefit from standard follow-up (medical follow-up, paramedical or specialized medical support depending on the development and needs).
干预措施: Ages and Stages Questionnaire (ASQ) (Other)
IBAIP Group
Children benefiting from assessment and intervention providing by a healthcare professional (physiotherapist or psychomotor therapist) trained and certified for IBAIP. This care will take place upon discharge from the hospital at the rate of one session per month for 6 months. The sessions will take place in the presence of at least one of the parents and at home. These children will also benefit from standard follow-up (medical follow-up, paramedical or specialized medical support depending on the development and needs).
干预措施: Parenting Stress Index (PSI) (Other)
IBAIP Group
Children benefiting from assessment and intervention providing by a healthcare professional (physiotherapist or psychomotor therapist) trained and certified for IBAIP. This care will take place upon discharge from the hospital at the rate of one session per month for 6 months. The sessions will take place in the presence of at least one of the parents and at home. These children will also benefit from standard follow-up (medical follow-up, paramedical or specialized medical support depending on the development and needs).
干预措施: Bayley Scales of Infant and Toddler Development (BSID-IV) (Other)
Control group
Children benefiting from standard care upon discharge from hospital with 1 medical consultation per month and, medical sepcialist and / or paramedical(physiotherapy, speech therapy, psychomotricity, etc.). consultations if indicated by the physician providing follow-up
干预措施: Standard Support (Other)
Control group
Children benefiting from standard care upon discharge from hospital with 1 medical consultation per month and, medical sepcialist and / or paramedical(physiotherapy, speech therapy, psychomotricity, etc.). consultations if indicated by the physician providing follow-up
干预措施: Ages and Stages Questionnaire (ASQ) (Other)
Control group
Children benefiting from standard care upon discharge from hospital with 1 medical consultation per month and, medical sepcialist and / or paramedical(physiotherapy, speech therapy, psychomotricity, etc.). consultations if indicated by the physician providing follow-up
干预措施: Parenting Stress Index (PSI) (Other)
Control group
Children benefiting from standard care upon discharge from hospital with 1 medical consultation per month and, medical sepcialist and / or paramedical(physiotherapy, speech therapy, psychomotricity, etc.). consultations if indicated by the physician providing follow-up
干预措施: Bayley Scales of Infant and Toddler Development (BSID-IV) (Other)
结局指标
主要结局
To assess the effect of the Infant Behavior Assessment and Intervention Program Program (IBAIP) in very preterm infants (< 33 weeks of gestation) on neurodevelopment at the corrected age of 2 years
时间窗: 2 years of corrected age
Patient neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development (BSID-IV) scale. This test studies the different notions of development: cognitive, language, motor skills, socio-emotional, behavioral, communication and autonomy.
To assess the effect of the Infant Behavior Assessment and Intervention Program Program (IBAIP) in very preterm infants (< 33 weeks of gestation) on neurodevelopment at the corrected age of 2 years
时间窗: 2 years of corrected age
Patient neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development (BSID-IV) scale. This test studies the different notions of development: cognitive, language, motor skills, socio-emotional, behavioral, communication and autonomy.
次要结局
- To assess the effect on the stress level of mothers and fathers(2 years of corrected age)
- Parental assessment of psychomotor development(2 years of corrected age)
- To assess the effect of IBAIP on the 5 sub-scores of BSID-IV: cognitive, language, motor, socio-emotional and behavioral adaptive(2 years of corrected age)
- To assess the effect on the stress level of mothers and fathers(2 years of corrected age)
- Parental assessment of psychomotor development(2 years of corrected age)