All participants will receive the experimental treatment with the Premie Pouch device.

All participants will receive the experimental treatment with the Premie Pouch device.
Premie Pouch: The Premie Pouch is an experimental device meant to manage the development of Deformational Plagiocephaly (DP) starting immediately following birth. The Premie Pouch has a concave-shaped foam insert that will provide a resting surface for the infant’s head and body that will eliminate uneven pressure on the infant’s occiput while maintaining correct body alignment. Also, the posterior neck area of the infant will be supported by a fixed bridge section of the foam insert. The Premie Pouch is designed specifically for the very low birth weight (VLBW) infant.

Premie Pouch

Sex: Female, Male

Race and Ethnicity Not Collected

Region of Enrollment

Cranial Abnormalities Were Measured at Enrollment

Frequency of participants with adverse events reported using the Premie Pouch Adverse Event Data Collection Tool.

Clinical decompensation of one subject, not device related, and not included in analysis. Did not meet minimal data requirement.

All Subjects Recieved the Study Device

Safety of Use of the Premie Pouch in VLBW Infants

Documented hours per day (24 hours) on the Premie Pouch device

All participants will received the experimental treatment with the Premie Pouch device.
Premie Pouch: The Premie Pouch is an experimental device meant to manage the development of Deformational Plagiocephaly (DP) starting immediately following birth. The Premie Pouch has a concave-shaped foam insert that will provide a resting surface for the infant’s head and body that will eliminate uneven pressure on the infant’s occiput while maintaining correct body alignment. Also, the posterior neck area of the infant will be supported by a fixed bridge section of the foam insert. The Premie Pouch is designed specifically for the very low birth weight (VLBW) infant.

Feasibility of Use of the Premie Pouch in VLBW Infants

Cranial index (An objective front to back and side to side, measure that quantifies head shape by dividing head width by length then multiplying it by 100%) for each of participants was measured at study completion. Participants falling within the normal range of 73%-85% had normal cranial index.

Number of Participants With Normal Cranial Index

To assess for cranial asymmetry of the head shape at study completion, the right anterior-posterior measures and left anterior-posterior measures of infant's head shapes were obtained. Cranial symmetry was defined as less than 8mm difference in the right and left anterior-posterior measures.

Number of Participants With Normal Cranial Symmetry

This the percentage or nurses that found the Premie Pouch device easy to use.

Nurses caring for participants in the study

Premie Pouch Ease of Use

Overall Study

Michele DeGrazia

Plagiocephaly

The Premie Pouch is an experimental device meant to manage the development of Deformational Plagiocephaly (DP) starting immediately following birth. The Premie Pouch has a concave-shaped foam insert that will provide a resting surface for the infant's head and body that will eliminate uneven pressure on the infant's occiput while maintaining correct body alignment. Also, the posterior neck area of the infant will be supported by a fixed bridge section of the foam insert. The Premie Pouch is designed specifically for the very low birth weight (VLBW) infant.

auditory perceptual disorders/kariyes

Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants

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