Feasibility and Safety of the Preemie Orthotic Device to Manage Deformational Plagiocephaly in Extremely Low Birth Weight Infants.

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.