Providing NICU-to-Home Dyadic Support for Very Preterm Infants and Their Families: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of Initiating SPEEDI After NICU Discharge
研究概览
简要总结
This feasibility study will evaluate delivery of the Supporting Play Exploration and Early Development Intervention after neonatal intensive care unit discharge for very preterm infants and their families.
Parent-preterm infant dyads will be assigned to homebased SPEEDI, telehealth SPEEDI, or a control group. SPEEDI is an early developmental intervention focused on supporting parent confidence, interpretation of infant behavioral cues, and parent-infant relationship building through developmentally appropriate play.
The study will assess feasibility of initiating SPEEDI 1 to 5 days after NICU discharge, including recruitment, retention, session attendance, activity log completion, intervention adherence, and delivery differences between homebased and telehealth SPEEDI. Family experiences and provider perspectives on strengths and barriers to SPEEDI implementation will also be evaluated.
详细描述
Very preterm infants and their families may experience challenges during the transition from the neonatal intensive care unit to home. Early intervention during this transition may support parent-infant relationships, infant development, and family confidence.
This feasibility study will evaluate whether the Supporting Play Exploration and Early Development Intervention can be initiated 1 to 5 days after NICU discharge and delivered in either homebased or telehealth contexts. The study will enroll 40 parent-preterm infant dyads from the University of Minnesota Masonic Children's Hospital NICU. Infants will have been born at less than 32 weeks gestation and discharged from the NICU between 35 and 44 weeks postmenstrual age.
After baseline assessment, parent-infant dyads will be assigned to homebased SPEEDI, telehealth SPEEDI, or control. Families in the homebased and telehealth groups will receive 10 intervention sessions across 15 weeks. SPEEDI is grounded in positive parent-infant relationship building and supports parents in interpreting infant behavioral cues and stress signs, increasing parenting confidence, and engaging infants in developmentally appropriate therapeutic play.
Assessments will occur at Visit 1, 1 to 5 days after NICU discharge; Visit 2, 15 weeks after baseline; and Visit 3, 30 weeks after baseline. Study assessments include parent questionnaires, parent-infant interaction videos scored with the Emotional Availability Scale, infant motor and developmental assessments, and infant activity measurement using the Motor Assessment of Infants with Jumpsuit at Visit 3.
The primary focus of the study is feasibility rather than efficacy. Feasibility measures include recruitment, dropout rate, intervention and assessment attendance, parent activity log completion, SPEEDI adherence, and differentiation between telehealth and homebased delivery. Qualitative interviews with families and Part C Early Intervention providers will be used to identify experiences, strengths, and barriers relevant to future implementation studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from participant and ability for participant to comply with study requirements
- •Stated willingness to comply with all study procedures, including consenting parent attendance at all study assessment and intervention visits
- •Stated willingness to comply with assignment to the homebased, telehealth, or control group
- •Infant gestational age of less than 32 weeks at birth
- •Infant hospitalized for more than 28 days following preterm birth
- •Infant discharged from the NICU between 35 and 44 weeks postmenstrual age
- •Consenting parent plans to live in Minnesota for a minimum of 6 months from recruitment
- •Consenting parent must be able to understand and speak English
- •Consenting parent age 18 years or older
排除标准
- •Infant has a genetic syndrome or metabolic disorder known to be progressive or to have developmental consequences
- •Infant has a condition that is not compatible with life
- •Prisoners with infants in the NICU
- •Pregnant women/persons
- •Non-English speakers
- •Employees of the researcher
- •Students of the researcher
研究组 & 干预措施
Homebased SPEEDI
Parent-preterm infant dyads assigned to this arm will receive SPEEDI in the family home. The intervention will include 10 sessions over 15 weeks after baseline, beginning within 1 week after Visit 1.
干预措施: Homebased SPEEDI (Behavioral)
Telehealth SPEEDI
Parent-preterm infant dyads assigned to this arm will receive SPEEDI via telehealth. The intervention will include 10 sessions over 15 weeks after baseline, beginning within 1 week after Visit 1.
干预措施: Telehealth SPEEDI (Behavioral)
Control
Parent-preterm infant dyads assigned to this arm will complete study assessments at baseline, 15 weeks after baseline, and 30 weeks after baseline, but will not receive the SPEEDI intervention as part of the study.
结局指标
主要结局
Feasibility of Initiating SPEEDI After NICU Discharge
时间窗: Baseline through 30 weeks after baseline
Feasibility will be assessed using recruitment of 40 dyads within 6 to 9 months, dropout rate less than 10%, intervention session attendance of 80%, assessment session attendance of 90%, parent activity log completion of 80%, SPEEDI interventionist and parent adherence to key protocol components of 90%, and less than 10% differentiation between telehealth and homebased SPEEDI components.
次要结局
- Family Experience With SPEEDI(Between 15 weeks and 30 weeks after baseline)
- Provider-Reported Strengths and Barriers to SPEEDI Implementation(During study participation, through study completion)