Clinical trial NCT03518736: Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention
Official title: Does Timing Matter? Efficacy of Parent Provided, Therapist Supported, Motor and Cognitive Intervention for Infants Born Very Preterm in the First Months of Life
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Preterm Infant
Cerebral Palsy
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-05-08
Enrollment: 85
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

  1. Infants must be medically stable, off ventilator support by 42 weeks of gestation
  2. 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Bayley Scaled of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of Problem Solving in Play
timeFrame: 6 months
measure: Gross Motor Function Measure (GMFM)
timeFrame: 6 months
measure: Test of Infant Motor Performance (TIMP)
timeFrame: 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: University of Southern California
name: Stacey Dusing, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dusing SC, Burnsed JC, Brown SE, Harper AD, Hendricks-Munoz KD, Stevenson RD, Thacker LR, Molinini RM. Efficacy of Supporting Play Exploration and Early Development Intervention in the First Months of Life for Infants Born Very Preterm: 3-Arm Randomized Clinical Trial Protocol. Phys Ther. 2020 Aug 12;100(8):1343-1352. doi: 10.1093/ptj/pzaa077.