Early Detection and Therapeutic Improvement of Motor Delay in High Risk Infants: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 222
- 试验地点
- 7
- 主要终点
- Bayley-4 motor score at 12-months corrected age
研究概览
简要总结
Study Aims
Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis.
Aim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age.
The investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. [an 8-point difference is considered a clinically meaningful difference]
Aim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay.
The Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age.
Aim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being.
The invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).
详细描述
The investigators will conduct a randomized controlled trial to evaluate the efficacy of a physical therapy intervention to improve motor function and reduce the severity of motor delays in infants admitted to the Neonatal Intensive Care Unit (NICU). The intervention is based on five principles: active learning, caregiver engagement, environmental enrichment, strengths-based approach, and dose. After enrollment, infants will be randomized to an intervention group or a standard of care group.
The intervention will start as early as possible (in the NICU) and continue until 12-months corrected age. Infants in the intervention group will receive up to two therapist visits per week in addition to standard of care physical therapy. Caregivers will be asked to work with their infant on activities provided by the therapist. The therapist will provide resources to support the caregiver in working on these activities with their child, and caregivers will be asked to complete the activities for as much time as possible, throughout the day. Therapists will work with caregivers to identify ways to incorporate activities into their day.
All infants in the study will be eligible to receive any services recommended or prescribed by their medical team and all families will be able to seek out and receive therapy or medical services outside of the study, without limitation.
All enrolled participants, regardless of group allocation, will complete sets of assessments at defined time points up to 12-months corrected age, with optional assessments at 18 and 24-months corrected age. The investigators will also ask all caregivers to complete surveys at defined time-points throughout the study to collect participant updates, information on infant development, and to monitor services received, caregiver engagement, and caregiver well-being. Caregivers may be invited to participate in a focus group and/or semi-structured interviews to evaluate study perceptions. Medical record review will be completed to evaluate standard-of-care services and medical history (as available).
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)
盲法说明
Clinicians involved in clinical assessments are blinded to study group
入排标准
- 年龄范围
- 33 Weeks 至 48 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NICU admission and qualifies for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to:
- •BW <1500 grams
- •Disorders of the central nervous system
- •Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic ischemic encephalopathy (HIE), meningitis)
- •HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled
- •includes "at risk for HIE" with 10-minute Apgar <7 plus pH<7.15 or base deficit >/=
- •Brain developmental abnormalities (hydrocephalus, microcephaly, cortical dysgenesis)
- •Cramped synchronous movements at term PMA
- •Bronchopulmonary dysplasia (BPD) defined as need for respiratory support at 36 weeks postmenstrual age in an infant born at <32 weeks of gestation.
- •Medically stable AND able to start intervention between 34-48 weeks PMA.
排除标准
- •(related to inability to complete intervention, sensor placement, or clinic assessments)
- •open wounds, skin condition precluding sensor placement
- •immune deficiencies requiring protective isolation
- •limb reduction defects
- •followed primarily in another clinic (including but not limited to meningomyelocele and related conditions/trisomy 21)
- •bleeding disorders or ongoing need for anticoagulation
- •palliative or hospice care (for life limiting conditions including, but not limited to trisomy 18, 13)
- •known visual impairment at the time of enrollment
- •DCFS custody
- •no English-speaking caregivers
- •any other condition that would preclude participation in the study, as determined by the PI
- •previously enrolled in competing randomized trial with developmental outcome variables
- •Each child's enrollment in the study will be approved by the child's neonatologist.
研究组 & 干预措施
Physical Therapy Intervention
Infants enrolled in this arm will receive the intervention in addition to standard of care
干预措施: Physical Therapy intervention (Other)
Standard of Care
Infants enrolled in this arm will receive standard of care
结局指标
主要结局
Bayley-4 motor score at 12-months corrected age
时间窗: Bayley-4 motor score assessed at 12-months CA will be the primary outcome
The Bayley-4 is an individually administered instrument that assesses the developmental functioning of infants and young children, aged between 16 days and 42 months, by observing the child's interaction with stimuli designed to engage them. It assesses five domains: Motor, Cognitive, Language, Social-emotional, and Adaptive behavior. The primary outcome will be the Bayley-4 motor score at 12-months corrected age. The standard scores range from 45-155 for the motor domain. Higher scores indicate better outcomes.
次要结局
- Bayley-4 Cognitive score Bayley-4 Cognitive score Bayley-4 Cognitive score(The Bayley-4 cognitive score will be assessed at 6-months corrected age (CA), 12-months CA, 18-months CA (optional), and 24-months CA (optional).)
- Pediatric Quality of Life Inventory (PedsQL)(PedsQL will be completed once during NICU stay (up to 45 days post enrolment), at one-and two-month intervals after enrollment; at 3-month corrected age (CA), 6-months CA, 9-months CA, 12-months CA, 18-months CA (optional), and 24-months CA (optional).)
- Movement quality assessed by wearable sensors(At each assessment timepoint, including study enrollment, monthly up to 3 months corrected age (CA), 3-month CA, 6-months CA, 9-months CA, 12-months CA, 18-months CA (optional), and 24-months CA (optional).)
研究者
Arun Jayaraman, PT, PhD
Investigator
Shirley Ryan AbilityLab