Purpose: To describe challenges in trying to implement a physical therapy-based early intervention program for infants with congenital heart disease.
Methods: Neonates with cyanotic congenital heart disease who had elective or emergency cardiac surgery at age 28 days or less participated in the study. Families were offered hospital-based physical therapy intervention from infant age of 3 months. Feasibility and efficacy of intervention were to be evaluated at 8 months.
Results: Study recruitment was protracted and then stopped. Anticipated sample size was limited by survival (86%) and recruitment rates (75%); cardiorespiratory and neurological complications led to lengthy admissions, precluding study participation. In addition, geographic constraints and families' general take-up of the services offered limited ability of those recruited to receive intervention at planned frequency and intensity.
Conclusions: Overall, data collected demonstrated infeasibility to evaluate effectiveness of hospital-based physical therapy intervention for this cohort of infants. Nonetheless, valuable data were gathered about factors leading to nonparticipation.
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