Does Timing Matter? A Clinical Trial of Supporting Play Exploration and Early Development Intervention (SPEEDI) for Infants Born Preterm in the First Months of Life.

OBJECTIVES: To evaluate the efficacy of an early delivered physical therapy intervention and to determine if timing of the intervention affects developmental outcomes. STUDY DESIGN: This multisite, three-arm, intervention-controlled trial compared the efficacy of SPEEDI Early (NICU start), SPEEDI_Late (starting 15 weeks later), and usual care (UC) to improve development, measured with the Bayley Scales of Infant and Toddler Development, 3rd edition, and parent-child dyadic interaction on the Emotional Availability Scale. SPEEDI is a motor-based, problem-solving intervention provided by an interventionist in collaboration with a caregiver. RESULTS: Eighty-three infants born very preterm with mean gestational age at birth of 26.5 ± 2.0 weeks were enrolled between 35-42 weeks of corrected gestational age. Combining SPEEDI groups, there was no difference between SPEEDI and UC. However, infants in SPEEDI_Early had significantly better cognitive scaled scores than infants in the SPEEDI_Late group through 24 months of age. Adjusting for baseline motor skills, infants in SPEEDI_Early had higher gross motor scaled scores through 24 months of age. A change in parent-child interaction in response to SPEEDI supports the intervention's theoretical model and provides a possible mechanism of action. CONCLUSIONS: Intervention which engages parents in supporting development in infants born very preterm may result in long-term developmental improvements when started in the neonatal intensive care unit. Delaying services by even 3 months appears to reduce efficacy of the intervention.