ABSTRACT
BACKGROUND: Premature infants are predisposed to developing deformational plagiocephaly. Deformational plagiocephaly may affect the infant's social well-being and neurobehavioral development. PURPOSE: This pilot study investigated the feasibility and safety of the preemie orthotic device (POD); a noncommercial, supportive orthotic device to manage deformational plagiocephaly. METHODS: The setting for this prospective, descriptive, phase 1 clinical trial was 2 urban and 1 suburban neonatal intensive care units that provided care for critically ill premature and term infants. Participants included a convenience sample of 10 premature extremely low-birth-weight infants weighing less than 1 kg. All participants received the experimental treatment with the POD. Time spent on the device with and without the supportive foam insert, provider perception, adverse events, and head shape measurements were collected to assess feasibility and safety of the device. RESULTS: Participants had a median gestational age of 25.4 weeks and median birth weight of 0.673 kg. The POD was used a median of 21.2 hours per day and the foam insert was used a median of 11.1 hours per day. At enrollment, 1 participant had a normal cranial index compared with 5 participants at study completion. All participants had normal cranial symmetry at study enrollment and completion. No device-related adverse events were reported. IMPLICATION FOR PRACTICE: The POD was found to be feasible and safe. Staff had favorable responses to the device. Recommendations by nursing staff included enlarging the device to extend its use. IMPLICATION FOR RESEARCH: Further studies are warranted to assess the POD's effectiveness.
Subject(s)
Equipment Design , Orthotic Devices , Plagiocephaly, Nonsynostotic/therapy , Attitude of Health Personnel , Feasibility Studies , Female , Humans , Infant , Infant, Extremely Low Birth Weight , Infant, Extremely Premature , Infant, Newborn , Intensive Care Units, Neonatal , Male , Nurses, Neonatal , Pilot Projects , Plagiocephaly, Nonsynostotic/prevention & controlABSTRACT
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.
