跳至主要内容
临床试验/NCT03518736
NCT03518736Unknown不适用

Does Timing Matter? Efficacy of Parent Provided, Therapist Supported, Motor and Cognitive Intervention for Infants Born Very Preterm in the First Months of Life

University of Southern California2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2019年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
85
试验地点
2
主要终点
Bayley Scaled of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores

研究概览

简要总结

Infants born very preterm (≤28 weeks of gestation) are at high risk of having developmental disabilities including cerebral palsy, coordination impairments, attention deficit and learning disabilities. Impairment including reduced postural control, movement variability, visual motor skills, and motor learning are common during the first months of life and are associated with later developmental disabilities. However, infant born very preterm rarely receive evidence based therapeutic intervention in the first months of life when basic science and animal intervention studies suggest the greatest efficacy. Barriers to enrollment in services delay the onset of services and delivery models rarely support targeted preventative intervention or enhanced parent engagement during in the transition from the neonatal intensive care unit (NICU) to home.

Targeted intervention supporting postural control and motor learning in the NICU have resulted in short term motor gains. Interventions that enhance parent's ability to read their infant's cues and provide engagement opportunities improve maternal mental health and infant social and cognitive outcomes in the short-term. The purpose of this randomized clinical trial is to evaluate the efficacy of an intervention that combines evidence based motor intervention and parent engagement to enhance the parent's ability to provide daily motor and cognitive opportunities resulting in improved motor and cognitive outcomes.

Supporting Play Exploration and Development Intervention (SPEEDI) uses guided participation to empower parents in reading infant's behavioral cues, identifying ideal times for interaction, and enriching the environment and learning opportunities. Parents participate in 5 session in 3 weeks while learning principles of engagement, readiness for interaction, and to provide early motor and cognitive learning opportunities. Parents provide 20 minutes of motor and cognitive play based enrichment daily for 12 weeks with bi-weekly physical therapist support. The parent is empowered to determine the infant's current abilities and advance the activities to the "Just Right Challenge" throughout the 12 weeks, likely continuing after the intervention.

The efficacy of SPEEDI will be assessed during delivery at 2 time point; the transition from the NICU to home (around the infant's due date) and at 3-4 months of adjusted age (after the infants due date). Ninety infants will be randomly assigned to a Usual Care group, SPEEDI_Early, or SPEEDI_Later group. Group differences will be assessed in developmental outcomes on the motor and cognitive scales of the Bayley Scales for Infant and Toddler Development as well as the Early Problem Solving Indicator and Gross Motor Function Measure at the end of each intervention period, 12 and 24 months of age.

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
— 至 6 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •All infants born very preterm (˂29 weeks of gestation) and cared for in the Neonatal Intensive Care Unit at the Children's Hospital of Richmond (CHoR) at Virginia Commonwealth University (VCU) or University of Virginia Hospital (UVa) will be offered an enrollment if they meet the following inclusion criteria.
  • •Infants must be medically stable, off ventilator support by 42 weeks of gestation
  • •live within 60 miles of either hospital (which are 75 miles apart). Early Intervention services in Virginia.
  • •A parent or LRA will also be enrolled in the study. Inclusion criteria for the adult is that they speak English and will be a caregiver for the enrolled infant.

排除标准

  • •Exclusion criteria include diagnosis of a genetic syndrome or unstable medical condition beyond 42 weeks of gestation.

研究组 & 干预措施

Usual Care

No Intervention

Infants randomly assigned to this arm will not receive any study intervention but will continue with any intervention in the community recommended by their health care team.

SPEEDI_Early

Experimental

Infants randomly assigned to this arm will participate in the SPEEDI intervention starting in the hospital and lasting for 4 months. This intervention includes 10 visits with a physical therapist and parent working together to advance an intervention program and 12 weeks of parent daily intervention.

In addition they will continue with any intervention in the community recommended by their health care team.

干预措施: Supporting Play Exploration and Developmental Intervention (SPEEDI) (Behavioral)

SPEEDI_Late

Experimental

Infants randomly assigned to this arm will participate in the SPEEDI intervention starting at 4 months post baseline or approximately 3 months after discharge from the hospital. This intervention includes 10 visits with a physical therapist and parent working together to advance an intervention program and 12 weeks of parent daily intervention.

In addition they will continue with any intervention in the community recommended by their health care team.

干预措施: Supporting Play Exploration and Developmental Intervention (SPEEDI) (Behavioral)

结局指标

主要结局

Bayley Scaled of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores

时间窗: 6 months

Scales scores for the cognitive and gross motor scales each have a mean of 10 and a standard deviation of 3. Higher scores are better.

次要结局

  • Test of Infant Motor Performance (TIMP)(3 months)
  • Assessment of Problem Solving in Play(6 months)
  • Gross Motor Function Measure (GMFM)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stacey Dusing

Associate Professor

University of Southern California

研究点 (2)

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