title: Prevention of deformational plagiocephaly in hospitalized infants using a new orthotic device.
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).
  
  
  METHODS
  A multisite, stratified, and randomized single-blinded study.
  
  
  METHODS
  Neonatal intensive care units (NICU) from three urban and one suburban hospital participated.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  Rotating the cranial cup with the moldable positioner provides a feasible, safe, and potentially efficacious therapy for prevention of DP.
authors.forename: Michele
authors.initials: M
authors.lastname: DeGrazia
authors.forename: Deborah
authors.initials: D
authors.lastname: Giambanco
authors.forename: Gretchen
authors.initials: G
authors.lastname: Hamn
authors.forename: Amy
authors.initials: A
authors.lastname: Ditzel
authors.forename: Lindsay
authors.initials: L
authors.lastname: Tucker
authors.forename: Kimberlee
authors.initials: K
authors.lastname: Gauvreau
mesh_terms: D002508:Cephalometry; D005240:Feasibility Studies; D005260:Female; D006257:Head / Q000002:abnormalities; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D008297:Male; D017283:Neonatal Nursing / Q000379:methods*; D009989:Orthotic Devices; D049068:Plagiocephaly, Nonsynostotic / Q000451:nursing / Q000517:prevention & control* / Q000534:rehabilitation*; D012399:Rotation; D016037:Single-Blind Method; D016683:Supine Position
keywords: NICU; brachycephaly; dolichocephaly; infant; neonatal intensive care unit; plagiocephaly; positional head shape deformity; scaphocephaly