Premature infants are predisposed to developing deformational plagiocephaly. Deformational plagiocephaly may affect the infant's social well-being and neurobehavioral development.
This pilot study investigated the feasibility and safety of the preemie orthotic device (POD); a noncommercial, supportive orthotic device to manage deformational plagiocephaly.
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.
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.
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.
Further studies are warranted to assess the POD's effectiveness.
Department of Pediatrics, Harvard Medical School, Boston, Massachusetts (Drs Knorr, Gauvreau, DeGrazia); Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts (Dr. Gauvreau); Division of Newborn Medicine (Dr. Knorr), Cardiovascular and Critical Care Services (Ms Porter and Serino, Dr DeGrazia), Department of Cardiology (Dr. Gauvreau), Boston Children's Hospital, Boston, Massachusetts; Division of Newborn Medicine, Winchester Hospital, Winchester, Massachusetts (Dr. Knorr); Department of Nursing, Brigham and Woman's Hospital, Boston, Massachusetts (Dr. Giambanco); Department of Nursing, St. Elizabeth's Medical Center, Brighton, Massachusetts (Ms Staude); Department of Medicine, U-Mass Memorial Medical Center, Worchester, Massachusetts (Ms St. Germain).
Correspondence: Michele DeGrazia, PhD, RN, NNP-BC, FAAN, Boston Children's Hospital, 7 North, 300 Longwood Ave, Boston, MA 02115 (Michele.DeGrazia@childrens.harvard.edu).
This work was supported by Boston Children's Hospital Innovation Acceleration Program Innovestment grant (2013, application #92); Boston Children's Hospital Department of Nursing; Plagio LLC, Avon, Massachusetts.
Dandle Lion Medical sublicensed the Preemie Orthotic Device (formerly known as the Preemie Pouch) for manufacture, distribution, and sale from Plagio LLC. Plagio LLC had sublicensed said device from Boston Children's Hospital. Dr DeGrazia, inventor of the device, has served as an unpaid consultant to Dandle Lion Medical regarding design changes for the Preemie Orthotic Device and may one day receive royalties from the sale of the device from Plagio LLC and Boston Children's Hospital.
The authors declare no conflicts of interest.