ABSTRACT
OBJECTIVE: To measure the feasibility, safety, and efficacy of the cranial cup device in a sample of hospitalized infants at risk for deformational plagiocephaly (DP). DESIGN: A multisite, stratified, and randomized single-blinded study. SETTING: Neonatal intensive care units (NICU) from three urban and one suburban hospital participated. PARTICIPANTS: Subjects included 62 infants with lengths of stay ≥ 14 days. METHODS: Nurses caring for infants in study group 1 used the moldable positioner. In study group 2, nurses rotated the moldable positioner and cranial cup devices using the cranial cup for a target goal of 12 hours/day. Both study groups received routine position changes. Outcome measures included hours of device use (feasibility), cardiorespiratory and emesis events (safety), and cranial measurements obtained at discharge (efficacy) by one of four, licensed orthotists who were blinded to the study. RESULTS: A total of 35 infants were randomized to study group 1 (moldable positioner) and 27 infants to study group 2 (moldable positioner and cranial cup). The median hours per day on the cranial cup was 10.7 (range 4.5-15.3). Emesis and cardiorespiratory events were equally distributed for the moldable positioner and cranial cup devices in study group 2. At discharge, more infants in study group 1 (46%, n = 16) exhibited abnormal cranial measurements than those in study group 2 (19%, n = 5) (p = .03). CONCLUSION: Rotating the cranial cup with the moldable positioner provides a feasible, safe, and potentially efficacious therapy for prevention of DP.
