Francyne Finlayson1, Joy Olsen2, Stacey C Dusing3, Andrea Guzzetta4, Abbey Eeles5, Alicia Spittle6. 1. The University of Melbourne, 161 Barry St, Carlton, Victoria 3053, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia. Electronic address: fsamara@student.unimelb.edu.au. 2. Murdoch Children's Research Institute, 50 Flemington Rd, Parkville, Victoria 3052, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia. 3. University of Southern California, 1540 Alcazar St #155, Los Angeles, California 90033, USA. 4. IRCCS Fondazione Stella Maris, Viale del Tirreno, 331, 56128 Calambrone, Pisa, Italy. 5. The University of Melbourne, 161 Barry St, Carlton, Victoria 3053, Australia; Murdoch Children's Research Institute, 50 Flemington Rd, Parkville, Victoria 3052, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia. 6. The University of Melbourne, 161 Barry St, Carlton, Victoria 3053, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia.
Abstract
BACKGROUND: An early intervention that enhances early development in infants born preterm, called 'Supporting Play, Exploration and Early Development Intervention' (SPEEDI) has been shown to be feasible in Virginia, United States, in a pilot study. Infants receive 10 therapy sessions until 3 months' corrected age (CA) (Phase 1[5 hospital sessions] and Phase 2[5 home-based sessions]) in addition to usual care. AIMS: To determine the feasibility of SPEEDI for very preterm infants in an Australian context. STUDY DESIGN: Prospective pilot feasibility randomised controlled trial. SUBJECTS:Infants born <30 weeks' gestation (GA), recruited between 34 and 38+6 weeks' postmenstrual age. OUTCOME MEASURES: Primary outcome was feasibility of SPEEDI, including recruitment rate, participant retention, sessions delivered, and therapy fidelity. Secondary outcome measures were developmental outcomes, including the Bayley Scales of Infant and Toddler Development - 3rd Edition (BSID-III) at 4 months' CA. RESULTS: Of 19 eligible infants, 17 consented, SPEEDI n = 8 and usual care n = 9 (mean GA = 26.7 weeks [SD 1.4], male n = 10). All participants completed the study, with 80% of SPEEDI therapy sessions completed (90% Phase 1; 72% Phase 2). On average, therapists and parents used 78% and 77% of SPEEDI strategies in each session respectively. Infants in the SPEEDI group had higher scores on the BSID-III for gross motor, and expressive and receptive language subscales at 4 months' CA. CONCLUSIONS: SPEEDI is a feasible intervention to deliver, and preliminary results suggest that SPEEDI may lead to improved motor and language outcomes at 4 months' CA, with results supporting future larger clinical trials.
RCT Entities:
BACKGROUND: An early intervention that enhances early development in infants born preterm, called 'Supporting Play, Exploration and Early Development Intervention' (SPEEDI) has been shown to be feasible in Virginia, United States, in a pilot study. Infants receive 10 therapy sessions until 3 months' corrected age (CA) (Phase 1[5 hospital sessions] and Phase 2[5 home-based sessions]) in addition to usual care. AIMS: To determine the feasibility of SPEEDI for very preterm infants in an Australian context. STUDY DESIGN: Prospective pilot feasibility randomised controlled trial. SUBJECTS:Infants born <30 weeks' gestation (GA), recruited between 34 and 38+6 weeks' postmenstrual age. OUTCOME MEASURES: Primary outcome was feasibility of SPEEDI, including recruitment rate, participant retention, sessions delivered, and therapy fidelity. Secondary outcome measures were developmental outcomes, including the Bayley Scales of Infant and Toddler Development - 3rd Edition (BSID-III) at 4 months' CA. RESULTS: Of 19 eligible infants, 17 consented, SPEEDI n = 8 and usual care n = 9 (mean GA = 26.7 weeks [SD 1.4], male n = 10). All participants completed the study, with 80% of SPEEDI therapy sessions completed (90% Phase 1; 72% Phase 2). On average, therapists and parents used 78% and 77% of SPEEDI strategies in each session respectively. Infants in the SPEEDI group had higher scores on the BSID-III for gross motor, and expressive and receptive language subscales at 4 months' CA. CONCLUSIONS: SPEEDI is a feasible intervention to deliver, and preliminary results suggest that SPEEDI may lead to improved motor and language outcomes at 4 months' CA, with results supporting future larger clinical trials.