Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention (TimeSPEEDI2)
Preterm Infant, Cerebral Palsy
About this trial
This is an interventional treatment trial for Preterm Infant
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.
- 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.
Exclusion Criteria:
- Exclusion criteria include diagnosis of a genetic syndrome or unstable medical condition beyond 42 weeks of gestation.
Sites / Locations
- University of Southern California
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
Usual Care
SPEEDI_Early
SPEEDI_Late
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.
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.
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.