Feasibility and Safety of the Preemie Orthotic Device to Manage Deformational Plagiocephaly in Extremely Low Birth Weight Infants.
Attitude of Health Personnel
Equipment Design
Feasibility Studies
Female
Humans
Infant
Infant, Extremely Low Birth Weight
Infant, Extremely Premature
Infant, Newborn
Intensive Care Units, Neonatal
Male
Nurses, Neonatal
Orthotic Devices
Pilot Projects
Plagiocephaly, Nonsynostotic
/ prevention & control
Journal
Advances in neonatal care : official journal of the National Association of Neonatal Nurses
ISSN: 1536-0911
Titre abrégé: Adv Neonatal Care
Pays: United States
ID NLM: 101125644
Informations de publication
Date de publication:
Jun 2019
Jun 2019
Historique:
pubmed:
7
2
2019
medline:
25
12
2019
entrez:
7
2
2019
Statut:
ppublish
Résumé
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.
Sections du résumé
BACKGROUND
BACKGROUND
Premature infants are predisposed to developing deformational plagiocephaly. Deformational plagiocephaly may affect the infant's social well-being and neurobehavioral development.
PURPOSE
OBJECTIVE
This pilot study investigated the feasibility and safety of the preemie orthotic device (POD); a noncommercial, supportive orthotic device to manage deformational plagiocephaly.
METHODS
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
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
CONCLUSIONS
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
CONCLUSIONS
Further studies are warranted to assess the POD's effectiveness.
Identifiants
pubmed: 30724785
doi: 10.1097/ANC.0000000000000585
doi:
Types de publication
Clinical Trial, Phase I
Journal Article
Langues
eng
Sous-ensembles de citation
IM